N/A
Completed N=164
Determining Metabolic Effects of Valproate and Antipsychotic Therapy
Source: ClinicalTrials.gov NCT00167934 ↗Enrolled (actual)
164
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.