At a glance
ClinicalIndex Comparison RecordN/ACompleted· 164 enrolled
Drug / intervention
Valproate +1 moredrug
Likely dose
Depakote ER 500–3000 mg orally every nightAI-extracted
Key inclusion· 4
- ✓DSM-IV diagnosis of schizophrenia (any type)
- ✓Stable on same antipsychotic medication for ≥6 months
- ✓No antipsychotic dose changes for 1 month prior to entry
- ✓No other medication changes for 1 month prior to entry
Key exclusion· 5
- ✕Substance abuse within 3 months of study entry
- ✕Involuntary legal status (per Missouri law)
- ✕Serious medical disorders confounding metabolic assessment: significant organ dysfunction, metabolic diseases, type 1 or 2 diabetes, pregnancy, endocrine disease, coagulopathy, anemia, acute infection
- ✕Currently on more than one antipsychotic medication
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Metabolic Effects of Valproate and Antipsychotic Therapy
In Brief
A clinical study evaluating Valproate and Placebo for Schizophrenia. Completed, enrolled 164 participants across 1 site.
Detailed Summary
This study will determine the metabolic processes responsible for high levels of blood glucose, metabolism disorders, and weight gain in people with schizophrenia who have been treated with antipsychotic medications in combination with valproate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)
Timeline
N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2004
First PostedSep 2005
Primary CompletionDec 2008
TodayJul 2026
First PostedSep 14, 2005
Enrollment StartDec 1, 2004
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 20.8 years ago
Interventions
Valproatedrug
Depakote ER 500 mg to 3000 mg taken every night
Placebodrug
Placebo given at same frequency as Valproate