Status:
COMPLETED
Determining Metabolic Effects of Valproate and Antipsychotic Therapy
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
NA
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 antipsycho...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00167934
Start Date
December 1 2004
End Date
December 1 2008
Last Update
February 10 2020
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110