Determining Metabolic Effects of Valproate and Antipsychotic Therapy

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Mental Health (NIMH); Washington University School of Medicine
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Antipsychotic Agents; Valproic Acid

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