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Find video protocols related to scientific articles indexed in Pubmed.
Incidence of Tardive Dyskinesia in Older Adult Patients Treated With Olanzapine or Conventional Antipsychotics.
J Geriatr Psychiatry Neurol
PUBLISHED: 07-11-2014
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The risk of persistent tardive dyskinesia (TD) was compared in patients with acute psychosis or agitation aged 55 years or older who were treated with olanzapine (OLZ) or conventional antipsychotic (CNV) drug therapy.
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A short-term, multicenter, placebo-controlled, randomized withdrawal study of a metabotropic glutamate 2/3 receptor agonist using an electronic patient-reported outcome device in patients with schizophrenia.
J Clin Psychopharmacol
PUBLISHED: 07-10-2014
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This 6-week, multicenter, randomized withdrawal, placebo-controlled trial sought to determine whether symptoms of physical dependence occur after abrupt cessation of pomaglumetad methionil (LY2140023 monohydrate), a metabotropic glutamate 2/3 receptor agonist, in patients with schizophrenia. Eligible outpatients, 18 to 65 years old who required a modification or initiation of antipsychotic medication received 4 weeks of pomaglumetad methionil during open-label treatment and then were randomized, double-blind, to continue pomaglumetad methionil or receive placebo for 2 weeks. The primary outcome compared results of the 3-day moving mean of the total score on the Discontinuation Symptom Checklist-Modified Rickels for pomaglumetad methionil-treated patients with those on placebo during the randomized withdrawal phase. An electronic patient-reported outcome (ePRO) device was used daily to record these results. During the withdrawal phase, 103 patients were randomized, and 98 patients completed the trial. There was no statistically significant evidence of withdrawal symptoms associated with placebo compared with pomaglumetad methionil continuation as measured by Discontinuation Symptom Checklist-Modified Rickels (P = 0.170). The results are supported by secondary analyses with the clinician-rated, Clinical Institute Withdrawal Assessment of Alcohol Scale Revised, which showed no statistically significant differences between treatment groups. Using the ePRO device, 82.5% of the patients achieved 75% to 100% of compliance. No discontinuations due to worsening of schizophrenia, serious adverse events, deaths, or seizures were reported during either phase of the study. These findings suggest that there is no evidence of withdrawal symptoms associated with the abrupt discontinuation of pomaglumetad methionil and that an ePRO device can be successfully used in a multicenter schizophrenia trial.
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Determinants of antipsychotic response in schizophrenia: implications for practice and future clinical trials.
J Clin Psychiatry
PUBLISHED: 05-13-2014
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Response to antipsychotics in schizophrenia is highly variable, and determinants are not well understood or used to design clinical trials.
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The longitudinal interplay between negative and positive symptom trajectories in patients under antipsychotic treatment: a post hoc analysis of data from a randomized, 1-year pragmatic trial.
BMC Psychiatry
PUBLISHED: 11-19-2013
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Schizophrenia is a highly heterogeneous disorder with positive and negative symptoms being characteristic manifestations of the disease. While these two symptom domains are usually construed as distinct and orthogonal, little is known about the longitudinal pattern of negative symptoms and their linkage with the positive symptoms. This study assessed the temporal interplay between these two symptom domains and evaluated whether the improvements in these symptoms were inversely correlated or independent with each other.
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Combining efficacy and completion rates with no data imputation: A composite approach with greater sensitivity for the statistical evaluation of active comparisons in antipsychotic trials.
Eur Neuropsychopharmacol
PUBLISHED: 10-08-2013
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Outcomes in RCTs of antipsychotic medications are often examined using last observation carried forward (LOCF) and mixed effect models (MMRM), these ignore meaning of non-completion and thus rely on questionable assumptions. We tested an approach that combines into a single statistic, the drug effect in those who complete trial and proportion of patients in each treatment group who complete trial. This approach offers a conceptually and clinically meaningful endpoint. Composite approach was compared to LOCF (ANCOVA) and MMRM in 59 industry sponsored RCTs. For within study comparisons we computed effect size (z-score) and p values for (a) rates of completion, (b) symptom change for complete cases, which were combined into composite statistic, and (c) symptom change for all cases using last observation forward (LOCF). In the 30 active comparator studies, composite approach detected larger differences in effect size than LOCF (ES=.05) and MMRM (ES=.076). In 10 of the 49 comparisons composite lead to significant differences (p?.05) where LOCF and MMRM did not. In 3 comparisons LOCF was significant, in 2 MMRM lead to significant differences whereas composite did not. In placebo controlled trials, there was no meaningful difference in effect size between composite and LOCF and MMRM when comparing placebo to active treatment, however composite detected greater differences than other approaches when comparing between active treatments. Composite was more sensitive to effects of experimental treatment vs. active controls (but not placebo) than LOCF and MMRM thereby increasing study power while answering a more relevant question.
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Negative symptoms in schizophrenia--the remarkable impact of inclusion definitions in clinical trials and their consequences.
Schizophr. Res.
PUBLISHED: 04-18-2013
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Negative symptoms are an important target for intervention in schizophrenia. There is lack of clarity in defining appropriate patients for negative symptom trials. While regulators, drug developers and academics have expressed positions in this regard, the implications of these definitions are not yet tested in large-scale trials and there is no consensus.
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Pomaglumetad methionil: no significant difference as an adjunctive treatment for patients with prominent negative symptoms of schizophrenia compared to placebo.
Schizophr. Res.
PUBLISHED: 04-01-2013
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This study tested whether treatment with pomaglumetad methionil (LY2140023 monohydrate), a metabotropic glutamate receptor 2/3 agonist compared with placebo (PBO), when added to a fixed-dose second-generation antipsychotic (SGA) demonstrated significantly greater reduction of negative symptoms, as assessed by the 16-item Negative Symptom Assessment scale (NSA-16), in patients with schizophrenia. This parallel-group, 16-week study enrolled adults with schizophrenia who were receiving standard of care (SOC) therapy, which included ?3months treatment with one of four SGAs: aripiprazole, olanzapine, risperidone, or quetiapine. Patients received either 20mg of twice daily LY2140023 monohydrate (LY2140023) or concurrent PBO SGA. The primary efficacy measure was change from baseline to final visit in NSA-16 total score. Secondary measures included additional measures of efficacy, cognition, and assessments of safety. Of 352 patients screened, 167 were randomly assigned to treatment, and 110 patients completed the study. Patients treated with LY2140023 and SOC failed to demonstrate a statistically significant improvement over patients treated with PBO and SOC on NSA-16 total score at endpoint or at any point during the study (all p>0.131). Changes in secondary efficacy measures were not significantly different between groups at endpoint. With the exception of vomiting which was greater in the LY2140023 group, there were no statistically significant differences in safety and tolerability measures. This study found no benefit of adjunctive LY2140023 versus PBO for negative symptoms in patients with schizophrenia receiving treatment with SOC. LY2140023 was generally well-tolerated in these patients.
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Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia.
Schizophr. Res.
PUBLISHED: 03-11-2013
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A number of pharmacological agents for treating negative symptoms in schizophrenia are currently in development. Unresolved questions regarding the design of clinical trials in this area were discussed at an international meeting in Florence, Italy in April 2012. Participants included representatives from academia, the pharmaceutical industry, and the European Medicines Agency (EMA). Prior to the meeting, participants submitted key questions for debate and discussion. Responses to the questions guided the discussion during the meeting. The group reached agreement on a number of issues: (1) study subjects should be under the age of 65; (2) subjects should be excluded for symptoms of depression that do not overlap with negative symptoms; (3) functional measures should not be required as a co-primary in negative symptom trials; (4) information from informants should be included for ratings when available; (5) Phase 2 negative symptom trials should be 12weeks and 26weeks is preferred for Phase 3 trials; (6) prior to entry into a negative symptom study, subjects should demonstrate clinical stability for a period of 4 to 6months by collection of retrospective information; and (7) prior to entry, the stability of negative and positive symptoms should be confirmed prospectively for four weeks or longer. The participants could not reach agreement on whether predominant or prominent negative symptoms should be required for study subjects.
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Bone loss associated with hyperprolactinemia in patients with schizophrenia.
Clin Schizophr Relat Psychoses
PUBLISHED: 02-12-2013
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Elevated prolactin (hyperprolactinemia) has been commonly reported during treatment with some antipsychotic drugs. A decrease in bone mineral density (BMD) may be related to elevated prolactin. The objective of this study was to determine the prevalence of low BMD in patients with schizophrenia treated with conventional antipsychotics or risperidone and to evaluate any potential relationship with treatment.
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Movement disorder profile and treatment outcomes in a one-year study of patients with schizophrenia.
Neuropsychiatr Dis Treat
PUBLISHED: 01-01-2013
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This study identified subgroups of patients with schizophrenia who differed on their movement disorder profile and compared their treatment outcomes.
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Analysis of gene variants previously associated with iloperidone response in patients with schizophrenia who are treated with risperidone.
J Clin Psychiatry
PUBLISHED: 07-12-2011
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We examined 6 single nucleotide polymorphisms (SNPs) previously reported to be associated with response to iloperidone therapy for association with response to risperidone therapy.
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Cost-effectiveness of early responders versus early nonresponders to atypical antipsychotic therapy.
Clinicoecon Outcomes Res
PUBLISHED: 04-19-2011
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To compare the cost-effectiveness of treating early responders versus early nonresponders to an atypical antipsychotic (risperidone) and the cost-effectiveness of treating early nonresponders maintained on risperidone versus those switched to olanzapine.
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Responses to antipsychotic therapy among patients with schizophrenia or schizoaffective disorder and either predominant or prominent negative symptoms.
Schizophr. Res.
PUBLISHED: 03-22-2011
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Patients with schizophrenia who have predominant negative symptoms are often considered less responsive to treatment. This analysis of patients with schizophrenia or schizoaffective disorder compares changes in symptom severity between those with predominant versus merely prominent negative symptoms. Prominent negative symptoms were defined by a baseline score of ?4 on at least 3, or ?5 on at least 2, of the 7 Positive and Negative Syndrome Scale (PANSS) negative subscale items. Predominant negative symptoms were defined by the foregoing plus a PANSS positive score of <19, a Barnes Akathisia score of <2, a Simpson-Angus score of <4, and a Calgary Depressive Scale score of <9. Adult patients with schizophrenia (n=227) or schizoaffective disorder (n=116) received either olanzapine (10-20mg/day, n=169) or quetiapine (300-700mg/day, n=174) for up to 24weeks. Data for both medications were pooled. Of the 343 patients enrolled in the study, 34.7% met the criteria for predominant negative symptoms, the remaining 65.3% being characterized only by their prominent negative symptoms. Changes in the severity of negative symptoms in both patient types largely followed similar trajectories during treatment, as reflected both in Marder PANSS negative subscale scores and in the Scale for Assessment of Negative Symptoms total and domain scores. Patients with either predominant or prominent negative symptoms therefore appear to respond similarly to atypical antipsychotic treatment. This distinction, incorporating an evaluation of the presence of positive, affective, and extrapyramidal symptoms, may therefore not have prognostic implications for the responsiveness of patients negative symptoms to treatment.
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Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia.
BMC Psychiatry
PUBLISHED: 03-21-2011
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In patients with schizophrenia, early non-response to oral antipsychotic therapy robustly predicts subsequent non-response to continued treatment with the same medication. This study assessed whether early response predicted later response when using a long-acting injection (LAI) antipsychotic.
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Trajectories of response to treatment with atypical antipsychotic medication in patients with schizophrenia pooled from 6 double-blind, randomized clinical trials.
Schizophr. Res.
PUBLISHED: 03-07-2011
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Research has identified distinct trajectories of antipsychotic response in patients with chronic schizophrenia in short-duration trials (~12 weeks). This post-hoc analysis identified trajectories in patients with chronic schizophrenia treated for ?24 weeks. We pooled data from 1990 patients with chronic schizophrenia from 6 randomized, double-blind, olanzapine-comparator trials of atypical antipsychotics. Trajectory analysis identified homogeneous subpopulations within the larger heterogeneous population. Baseline demographics were compared between the identified latent classes. Five distinct response trajectories based on Positive and Negative Syndrome Scale (PANSS) Total score were identified: Dramatic Responders (n=47/1990, 2.4%), severely-ill patients (PANSS=124) with rapid and sustained improvement (51%) by Week 3; Partial Responders (n=1802/1990, 90.6%), moderately-ill (PANSS=90) with minimal improvement (21%) by Week 4, and little further improvement; Partial Responders-Unsustained (Late) (n=32/1990, 1.6%), markedly-ill (PANSS=95) with minimal initial improvement followed by worsening after Week 12; Partial Responders-Unsustained (Early) (n=28/1990, 1.4%), markedly-ill (PANSS=102) with minimal initial improvement followed by worsening after Week 8; and Delayed Responders (n=81/1990, 4.1%), markedly-to-severely-ill (PANSS=113) with minimal (11%) improvement at Week 8, but noticeable improvement thereafter (49%). Significant differences were noted for several baseline characteristics (p<.05) and discontinuation rates (46%-72%). Dramatic Responders were younger and more likely to be female and Hispanic with higher baseline illness severity. Analysis of antipsychotic response over 24 weeks in a large, pooled, heterogeneous population treated for schizophrenia revealed 5 distinct trajectories. Most patients had modest and sustained improvements during atypical antipsychotic treatment, regardless of their baseline illness severity, representing a partial response to currently available treatments.
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Identification of early changes in specific symptoms that predict longer-term response to atypical antipsychotics in the treatment of patients with schizophrenia.
BMC Psychiatry
PUBLISHED: 02-09-2011
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To identify a simple decision tree using early symptom change to predict response to atypical antipsychotic therapy in patients with (Diagnostic and Statistical Manual, Fourth Edition, Text Revised) chronic schizophrenia.
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Development of a clinician questionnaire and patient interview to assess reasons for antipsychotic discontinuation.
Psychiatry Res
PUBLISHED: 01-19-2011
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Time to treatment discontinuation and rates of discontinuation are commonly used when evaluating effectiveness of antipsychotic medication. However, less is known about reasons for discontinuation. The purpose of this study was to develop two measures of reasons for discontinuation or continuation of antipsychotics for the treatment of schizophrenia. Based on literature review, a patient interview pilot study, and expert panel input, two measures were drafted: the clinician-reported Reasons for Antipsychotic Discontinuation/Continuation Questionnaire (RAD-Q) and the patient-reported Reasons for Antipsychotic Discontinuation/Continuation Interview (RAD-I). Patients and clinicians completed the draft measures and structured cognitive debriefing interviews. For the draft instruments, reasons for discontinuation/continuation were divided into 3 categories: therapeutic benefits (positive symptoms, negative symptoms, mood, cognition, functional status), adverse events, and reasons other than direct effects of the medication (e.g., cost, inadequate social support). In cognitive debriefings, 10 clinicians and 15 patients indicated that the RAD-Q and RAD-I were clear, easy to complete, and comprehensive. Clinicians and patients suggested minor revisions, and the instruments were revised accordingly. The RAD-Q and RAD-I appear to be useful instruments for assessing reasons for antipsychotic discontinuation and continuation. The next step is a psychometric evaluation of the measures in a larger sample.
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Cost-effectiveness of olanzapine vs. aripiprazole in the treatment of schizophrenia.
Curr Med Res Opin
PUBLISHED: 11-26-2010
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Information about the cost-effectiveness of aripiprazole relative to other atypical antipsychotics in the treatment of patients with schizophrenia is limited. This information is needed to better inform drug formulary managers and population-based health care decision makers. The objective of this study was to compare the cost-effectiveness of olanzapine to aripiprazole in the treatment of schizophrenia from the perspective of public payers in the United States.
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Predictive value of early changes in triglycerides and weight for longer-term changes in metabolic measures during olanzapine, ziprasidone or aripiprazole treatment for schizophrenia and schizoaffective disorder post hoc analyses of 3 randomized, controll
J Clin Psychopharmacol
PUBLISHED: 11-25-2010
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The objective of this study was to determine if early changes in triglycerides and weight may be useful in predicting longer-term changes in weight and other metabolic parameters. Data were from three 24- to 28-week randomized, controlled studies comparing olanzapine to ziprasidone or aripiprazole for treatment of schizophrenia. Analyses were restricted to completers with fasting laboratory data at all protocol specified time points. Analyses were primarily descriptive and included mean changes and categorical outcomes. In all treatment groups, participants who did not experience a 20 mg/dL or greater increase in triglycerides at early time points were unlikely to experience a change of 50 mg/dL or more in triglycerides after 6 months. Negative predictive values were 83% to 95%. However, early change in triglycerides was not useful for predicting later change in glucose, cholesterol, or weight. Similarly, early weight change gave robust negative predictive values for longer-term weight change (?10 kg), but not for change in glucose or cholesterol. Lack of early elevation in triglyceride concentrations was predictive of later lack of substantial increase in triglycerides in olanzapine-, ziprasidone-, and aripiprazole-treated participants. Lack of early elevation in weight was predictive of later lack of substantial increase in weight in all 3 treatment groups. Early monitoring of triglyceride concentrations and weight may help clinicians assess risk that individuals will experience significant increase in triglycerides or weight gain, allowing assessments of potential risks and benefits earlier in treatment. Clinical monitoring is advised throughout treatment for all patients.
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Impact of race on efficacy and safety during treatment with olanzapine in schizophrenia, schizophreniform or schizoaffective disorder.
BMC Psychiatry
PUBLISHED: 11-03-2010
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To examine potential differences in efficacy and safety of treatment with olanzapine in patients with schizophrenia of white and black descent.
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Reasons for discontinuation and continuation of antipsychotics in the treatment of schizophrenia from patient and clinician perspectives.
Curr Med Res Opin
PUBLISHED: 09-04-2010
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To identify reasons for discontinuation and continuation of antipsychotic medications in the treatment of schizophrenia from the patients and their clinicians perspectives.
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Early onset of antipsychotic action in schizophrenia: evaluating the possibility of shorter acute efficacy trials.
J Clin Psychopharmacol
PUBLISHED: 05-18-2010
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Extended placebo-controlled clinical trials in schizophrenia research pose an ethical challenge. This study examines factors that have implications for the design and duration of placebo-controlled acute efficacy trials: Does early response discriminate active drug (AD) from placebo, and are the early differences sustained over time? A post hoc pooled analysis of 2 randomized 6-week double-blind clinical trials was performed comparing patients with schizophrenia treated with placebo or low-dose olanzapine (1 mg/d; placebo/low dose [PBO] group, n = 170) to patients treated with a 10- to 20-mg/d dose of haloperidol or medium- to high-dose olanzapine (7.5 to 17.5 mg/d; AD group, n = 252). Mixed-model repeated-measure analysis tested for group differences. Power analysis was undertaken to compare study designs with shorter durations. At 2 weeks, the mean reduction in the Brief Psychiatric Rating Scale total score was significantly greater for the AD group (-10.1) compared with the PBO group (-4.1; P < 0.001); this difference was sustained until the study ended (6 weeks). A higher proportion of early treatment responders were observed for the AD group (52%) compared with the PBO group (29%; P < 0.001). Early nonresponse to placebo or drug was predictive of subsequent nonresponse (negative predictive value: PBO = 95%, AD = 84%). Power analysis indicates that the placebo-drug differences are robust at 2 weeks. Treatment responders from the AD and the PBO groups followed a similar response path. Early response to antipsychotic treatment discriminated AD from placebo. Reducing placebo-controlled clinical trials from 6 weeks to 2 to 4 weeks was found to be a viable option for efficacy identification in acutely ill patients.
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Predictors of switching antipsychotic medications in the treatment of schizophrenia.
BMC Psychiatry
PUBLISHED: 03-04-2010
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To identify patient characteristics and early changes in patients clinical status that best predict subsequent switching of antipsychotic agents in the long-term treatment of schizophrenia.
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Early response to antipsychotic therapy as a clinical marker of subsequent response in the treatment of patients with first-episode psychosis.
Psychiatry Res
PUBLISHED: 02-11-2010
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Early response to antipsychotic medication has been shown to accurately predict later response to continued use of the same treatment in patients with chronic schizophrenia. This study examines whether this predictive pattern exists for patients with first-episode psychosis. We used a data-driven threshold for early response of ? 26.2% improvement from baseline on the Positive and Negative Syndrome Scale (PANSS(0-6)) Total score to determine whether response at Week 2 of treatment may predict response at Week 12 in a randomized, double-blind trial of olanzapine versus haloperidol for treatment of patients with first-episode psychosis (N=225). Later response was defined as a ? 40% and ? 50% improvement in PANSS Total(0-6) score and as remission. At Week 2, 43% (97/225) of patients were identified as early responders. At a threshold for later response of ? 50% improvement in PANSS(0-6) Total score, early non-response most strongly predicted later non-response, demonstrating high specificity (74%) and high negative predictive value (80%). As had been seen in the treatment of patients with chronic schizophrenia, early non-response was a robust predictor of subsequent non-response in the treatment of patients with first-episode psychosis.
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Challenging the assumption that improvement in functional outcomes is delayed relative to improvement in symptoms in the treatment of schizophrenia.
Schizophr. Res.
PUBLISHED: 01-15-2010
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Functional improvement is generally thought to be distal to improvement in psychiatric symptoms in patients with schizophrenia. In this study, we assessed the effects of early response/non-response to an atypical antipsychotic across multiple outcome measures.
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Optimal thresholds of early response to atypical antipsychotics: application of signal detection methods.
Schizophr. Res.
PUBLISHED: 05-26-2009
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Identify the optimal magnitude of response to antipsychotic medication at various early time points that best predicts subsequent non-response at 8 weeks.
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Olanzapine plasma concentrations after treatment with 10, 20, and 40 mg/d in patients with schizophrenia: an analysis of correlations with efficacy, weight gain, and prolactin concentration.
J Clin Psychopharmacol
PUBLISHED: 05-15-2009
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Objectives of the study were to evaluate the relationship between olanzapine plasma concentrations and efficacy, prolactin, and weight and to assess effects of smoking, sex, and race on the pharmacokinetic characteristics of oral olanzapine up to 40 mg/d. Patients were randomly allocated to olanzapine 10, 20, or 40 mg/d for 8 weeks. Olanzapine concentrations in 634 samples from 380 patients were analyzed. Mean sample collection time was approximately 15 hours after dose for all groups. Mean olanzapine concentrations were 19.7 +/- 11.4, 37.9 +/- 22.8, and 74.5 +/- 43.7 ng/mL for 10-, 20-, and 40-mg doses, respectively. Olanzapine concentration and Positive and Negative Syndrome Scale improvement were not significantly correlated. Change in both weight and prolactin showed significant dose response. Prolactin concentration was correlated with olanzapine concentration (r = 0.46, P < 0.001). No significant correlation between olanzapine concentration and weight change was observed. Olanzapine concentrations were lower in self-reported smokers (16.5 +/- 9.6, 34.2 +/- 20.8, and 60.9 +/- 34.6 ng/mL) than in self-reported nonsmokers (25.6 +/- 12.3, 43.4 +/- 24.7, and 113.2 +/- 44.0 ng/mL) for 10-, 20-, and 40-mg doses, respectively (P
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Maintenance of response with atypical antipsychotics in the treatment of schizophrenia: a post-hoc analysis of 5 double-blind, randomized clinical trials.
BMC Psychiatry
PUBLISHED: 03-31-2009
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How long an antipsychotic is effective in maintaining response is important in choosing the correct treatment for people with schizophrenia. This post-hoc analysis describes maintenance of response over 24 or 28 weeks in people treated for schizophrenia with olanzapine, risperidone, quetiapine, ziprasidone, or aripiprazole.
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Predictors and correlates for weight changes in patients co-treated with olanzapine and weight mitigating agents; a post-hoc analysis.
BMC Psychiatry
PUBLISHED: 03-28-2009
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This study focuses on exploring the relationship between changes in appetite or eating behaviors and subsequent weight change for adult patients with schizophrenia or bipolar disorder treated with olanzapine and adjunctive potential weight mitigating pharmacotherapy. The aim is not to compare different weight mitigating agents, but to evaluate patients characteristics and changes in their eating behaviors during treatment. Identification of patient subgroups with different degrees of susceptibility to the effect of weight mitigating agents during olanzapine treatment may aid clinicians in treatment decisions.
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A 28-week, randomized, double-blind study of olanzapine versus aripiprazole in the treatment of schizophrenia.
J Clin Psychiatry
PUBLISHED: 03-24-2009
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To evaluate the effectiveness of olanzapine versus aripiprazole in patients with schizophrenia.
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Long-term healthcare costs and functional outcomes associated with lack of remission in schizophrenia: a post-hoc analysis of a prospective observational study.
BMC Psychiatry
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Little is known about the long-term outcomes for patients with schizophrenia who fail to achieve symptomatic remission. This post-hoc analysis of a 3-year study compared the costs of mental health services and functional outcomes between individuals with schizophrenia who met or did not meet cross-sectional symptom remission at study enrollment.
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Construct validity of 2 measures to assess reasons for antipsychotic discontinuation and continuation from patients and clinicians perspectives in a clinical trial.
BMC Med Res Methodol
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Little is known about the specific reasons for antipsychotic discontinuation or continuation from patients or clinicians perspectives. This study aimed to assess the construct validity of 2 new measures of the Reasons for Antipsychotic Discontinuation/Continuation (RAD): RAD-I (a structured interview assessing the patients perspective) and RAD-Q (a questionnaire assessing the clinicians perspective).
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Validation of a patient interview for assessing reasons for antipsychotic discontinuation and continuation.
Patient Prefer Adherence
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The Reasons for Antipsychotic Discontinuation Interview (RAD-I) was developed to assess patients perceptions of reasons for discontinuing or continuing an antipsychotic. The current study examined reliability and validity of domain scores representing three factors contributing to these treatment decisions: treatment benefits, adverse events, and distal reasons other than direct effects of the medication.
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Validation of a clinician questionnaire to assess reasons for antipsychotic discontinuation and continuation among patients with schizophrenia.
Psychiatry Res
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The Reasons for Antipsychotic Discontinuation Questionnaire (RAD-Q) was designed to assess clinicians perceptions of reasons for antipsychotic discontinuation or continuation. The current study examined psychometric properties of this instrument and patterns of antipsychotic discontinuation. The sample of 121 patients (81 discontinuation, 40 continuation) with schizophrenia or schizoaffective disorder was 66.9% male, with a mean age of 41.6 years. Treating clinicians reported a mean of 4.1 reasons for discontinuation and 7.5 reasons for continuation. RAD-Q domain scores were derived to quantify the impact of three factors on the decision to discontinue or continue: treatment benefits, adverse events, and distal reasons other than direct effects of the medication. Analysis of inter-rater reliability indicated an acceptable degree of agreement between clinicians (weighted Kappa for discontinuation scores=0.70-0.78). Correlations with symptom measures (Clinical Global Impression-Schizophrenia Scale (CGI-SCH), Positive and Negative Syndrome Scale (PANSS)) supported convergent validity of the benefits domain score (r=0.28-0.47; all p<0.05). Domain scores discriminated among groups of patients differing in clinician and patient-reported clinical variables. Results suggest that the RAD-Q is a useful detailed measure of reasons for antipsychotic discontinuation and continuation. Findings indicate that clinicians usually report multiple reasons for discontinuation, rather than a single reason for each patient.
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Comparison of patients undergoing switching versus augmentation of antipsychotic medications during treatment for schizophrenia.
Neuropsychiatr Dis Treat
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It is often difficult to determine whether a patient may best benefit by augmenting their current medication or switching them to another. This post-hoc analysis compares patients clinical and functional profiles at the time their antipsychotic medications were either switched or augmented. Adult outpatients receiving oral antipsychotic treatment for schizophrenia were assessed during a 12-month international observational study. Clinical and functional measures were assessed at the time of first treatment switch/augmentation (0-14 days prior) and compared between Switched and Augmented patient groups. Due to low numbers of patients providing such data, interpretations are based on effect sizes. Data at the time of change were available for 87 patients: 53 Switched and 34 Augmented. Inadequate response was the primary reason for treatment change in both groups, whereas lack of adherence was more prevalent in the Switched group (26.4% vs 8.8%). Changes in clinical severity from study initiation to medication change were similar, as indicated by Clinical Global Impressions-Severity scores. However, physical and mental component scores of the 12-item Short-Form Health Survey improved in the Augmented group, but worsened in the Switched group. These findings suggest that the patients worsening or lack of meaningful improvement prompts clinicians to switch antipsychotic medications, whereas when patients show some improvement, clinicians may be more likely to try bolstering the improvements through augmentation. Current findings are consistent with physicians stated reasons for switching versus augmenting antipsychotics in the treatment of schizophrenia. Confirmation of these findings requires further research.
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Early Perception of Medication Benefit Predicts Subsequent Antipsychotic Response in Schizophrenia.
Clin Schizophr Relat Psychoses
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Background: An easy-to-administer tool for predicting response to antipsychotic treatment could improve the acute management of patients with schizophrenia. We assessed whether a patients perception of medication benefit early in treatment could predict subsequent response or non-response to continued use of the same treatment.Method: This post-hoc analysis used data from a randomized, open-label trial of antipsychotics for treatment of schizophrenia in which attitudes about medication adherence was assessed after 2 weeks of antipsychotic treatment using the Rating of Medication Influences (ROMI) scale. The analysis included 439 patients who had Positive and Negative Syndrome Scale (PANSS) and ROMI scale data at Weeks 2 and 8. Scores on the ROMI subscale Perceived Medication Benefit factor were used to predict subsequent antipsychotic response at Week 8, defined as a ?20% reduction from baseline on the PANSS. Logistic regression was used to identify a cut-off score for the Perceived Medication Benefits factor that could accurately identify antipsychotic responders vs. nonresponders at Week 8.Results: A score of ?2.75 (equal to a mean subscale score of ?11.00) on the ROMI scale Perceived Medication Benefit factor at Week 2 predicted response at Week 8 with high specificity (72%) and negative predictive value (70%), moderate sensitivity (44%) and positive predictive value (47%), and with a 38% misclassification rate.Conclusion: A brief assessment of the patients perception of medication benefit at 2 weeks into treatment appears to be a good predictor of subsequent response and non-response after 8 weeks of treatment with the same antipsychotic.
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What is Visualize?

JoVE Visualize is a tool created to match the last 5 years of PubMed publications to methods in JoVE's video library.

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We use abstracts found on PubMed and match them to JoVE videos to create a list of 10 to 30 related methods videos.

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In developing our video relationships, we compare around 5 million PubMed articles to our library of over 4,500 methods videos. In some cases the language used in the PubMed abstracts makes matching that content to a JoVE video difficult. In other cases, there happens not to be any content in our video library that is relevant to the topic of a given abstract. In these cases, our algorithms are trying their best to display videos with relevant content, which can sometimes result in matched videos with only a slight relation.