Determining Metabolic Effects of Valproate and Antipsychotic Therapy

Completed · Not applicable · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00167934

Run by

Washington University School of Medicine

People needed

164

Starts

2004-12-01

Expected to finish

2008-12-01

Last updated by the study team

2020-02-10

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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