Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to assess the 14-day and 12-week safety and efficacy of Depakote ER used in combination with either olanzapine or risperidone versus antipsychotic monotherapy with olanzapine or risperidone for the treatment of schizophrenia.

Official Title
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A Study of the Safety and Efficacy of Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Divalproex Sodium Extended-Release Tablets
* Drug: Olanzapine
* Drug: Risperidone


Participation Criteria
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Eligibility Criteria
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KEY INCLUSION CRITERIA: Acute exacerbation of schizophrenia as defined by: subject recently hospitalized or is in the process of being admitted to a hospital or an acute care inpatient psychiatric treatment facility; and has a PANNS Total score of 70 or greater at the time of screening and at randomization based on a 1-7 point scale; and has a score on any two of the four items from psychosis cluster of the BPRS (extracted from the PANSS) that correspond to the positive symptoms (hallucinatory behavior, unusual thought content, conceptual disorganization and suspiciousness) totaling 8 or greater; and has a total of 6 or greater on one of the following two pairs of items from the BPRS (extracted from the PANSS): hostility and uncooperativeness or excitement and tension. Current DSM-IV-TR diagnosis of schizophrenia as confirmed by the SCID Positive response to antipsychotics in the previous 2 years KEY EXCLUSION CRITERIA: Current diagnosis of schizoaffective disorder, drug-induced psychosis, manic episode or major depressive episode. At the time of screening, has been hospitalized for more than 14 days for the current episode Has ever taken clozapine Has had more than 3 psychiatric hospitalizations in the previous 6 months or has had more than 8 weeks of psychiatric hospitalization in the previous 12 months Has serious violent, homicidal, suicidal ideation Has received depot medications fluphenazine decanoate and/or haloperidol decanoate within 2 or 4 weeks prior to randomization respectively Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines History of alcohol or substance dependence within the past month Has taken any valproate product for a psychiatric indication within the previous 30 days Has received an investigational drug within the last 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Divalproex Sodium Extended-Release Tablets|nan|
|Drug: Olanzapine|nan|
|Drug: Risperidone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The psychiatric rating scale battery will include the PANSS, the CGI Scale, and the CDSS. The NOSIE, Overall Treatment Evaluation, Burden Questionnaire, and Quality of Life Scale. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The movement rating scale battery will include the Simpson-Angus Scale (SAS), the Barnes Akathisia Scale (BAS), and the Abnormal Involuntary Movement Scale (AIMS). |  |  |