Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia
Summary
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.
Study Design
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Schizophrenia
Intervention
Divalproex Sodium Extended-Release Tablets, Olanzapine, Risperidone
Location
Birmingham
Alabama
United States
Status
Completed
Source
Abbott
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00073164
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tablets, Enteric-coated
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Risperidone
A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.
Sodium, Dietary
Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.
Schizophrenia, Paranoid
A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.
Schizophrenia, Catatonic
A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.
Clinical Trials
Fasting Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a single,...
Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that of...
Divalproex Sodium 500 mg Extended Release Tablets Under Non-Fasting Conditions
This study was designed to compare the relative bioavailability (rate and extent of absorption) of Divalproex Sodium ER Tablets 500 mg with that of Depakote® ER Tablets 500 mg following a...
The purpose of this study is to assess the efficacy and safety of continued combination therapy using Depakote plus olanzapine, vs. Depakote monotherapy and olanzapine monotherapy in stabl...
Divalproex ER vs. Risperidone for Bipolar Disorder With Comorbid Substance Use Disorder
The primary objective is to evaluate the safety and efficacy of divalproex extended release (ER) compared to risperidone in the treatment of bipolar disorder with comorbid substance use di...
PubMed Articles
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Atypical or second-generation antipsychotics (SGAs) are associated with excessive body weight gain (BWG) and other components of metabolic syndrome. Among all SGAs, clozapine and olanzapine are known...
OBJECTIVE: The metabolic side effects of second-generation antipsychotics (SGA) are serious and have not been compared head to head in a meta-analysis. We conducted a meta-analysis of studies comparin...
