N/A
N=164
Determining Metabolic Effects of Valproate and Antipsychotic Therapy
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00167934 ↗Enrolled (actual)
164
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Change From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 Weeks — -0.51; 2.03 percent change — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Valproate (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 Weeks |
-0.51; 2.03 | < 0.0001 sig |
| PRIMARY Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal) |
0.27; -0.35 | 0.04 sig |
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.
Eligibility Criteria
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
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
Data sourced from ClinicalTrials.gov (NCT00167934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.