Determining Metabolic Effects of Valproate and Antipsychotic Therapy

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Valproate

• Registration Number: NCT00167934
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

This project aims to study the whole-body metabolic processes responsible for hyperglycemia, dyslipidemia and increased adiposity in schizophrenia patients treated with antipsychotic medications in combination with valproate. The project hypothesizes that combined treatment with valproate and antipsychotic medications will decrease insulin sensitivity at the...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2015-11-18
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-28
• Results First Posted: 2020-02-10
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Meets DSM-IV criteria for schizophrenia, any type, treated with the same antipsychotic for at least 6 months
• No antipsychotic medication dose changes for 1 month, and no other medication changes for 1 month prior to study entry

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Exclusion Criteria

• Meets DSM-IV criteria for substance abuse within 3 months of study entry
• Involuntary legal status (as per Missouri law)
• Any serious medical disorder that may confound the assessment of relevant biologic measures or diagnosis, including: significant organ system dysfunction, metabolic diseases, type 1 or 2 diabetes mellitus, pregnancy, endocrine disease, coagulopathy, anemia, or acute infection
• Currently taking more than one antipsychotic medication
• Currently taking prescription medications (except certain psychotropic medications as discussed below), including oral contraceptive pills, any glucose lowering agent, lipid lowering agent, exogenous testosterone, recombinant human growth hormone, or any other endocrine agent that might confound substrate metabolism

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	50% of participants will receive placebo
Experimental	Valproate	50% of participants will receive Depakote ER

Primary Outcome Measures

Name	Time	Method
Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal)	Measured at baseline and Week 12
Change From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 Weeks	Measured at baseline and Week 12	Change in body composition (total body fat) was assessed using dual energy x-ray absorptiometry

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States