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Determining Metabolic Effects of Valproate and Antipsychotic Therapy

Information source: National Institute of Mental Health (NIMH)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Valproate (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Dan W. Haupt, MD, Principal Investigator, Affiliation: Washington University School of Medicine

Overall contact:
Martha J. Hessler, BS, Phone: 314-362-2423, Email: hesslema@psychiatry.wustl.edu

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.

Clinical Details

Official title: Metabolic Effects of Valproate and Antipsychotic Therapy

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Oral glucose tolerance test (fsOGTT) and hyperinsulinemic pancreatic clamp

Secondary outcome: Body composition using dual energy x-ray absorptiometry, magnetic resonance scans, and anthropomorphic measurements

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 combination with valproate. The project hypothesizes that combined treatment with valproate and antipsychotic medications will decrease insulin sensitivity at the level of skeletal muscle, liver and adipose tissue, in comparison to antipsychotic monotherapy. The decrease in insulin sensitivity is hypothesized to be associated with defects in glucose and lipid metabolism and increased adiposity Treatment effects of antipsychotic/valproate combination therapy on different components of insulin secretion and action, and treatment effects on abdominal versus peripheral adiposity, are unknown despite the availability of gold-standard methods and the prognostic significance of these issues. Relevant data are needed to target basic research, to identify the potential for acute and long-term complications, and to plan therapeutic interventions. The following specific aims will be addressed in non-diabetic schizophrenia patients treated with atypical antipsychotics who will be randomized to open label treatment with either valproate or no adjuvant. Evaluations are performed at baseline and 3 months of treatment.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Martha J. Hessler, BS, Phone: 314-362-2423, Email: hesslema@psychiatry.wustl.edu

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Elizabeth T Westerhaus, MA, Phone: 314-747-1134, Email: westerhe@psychiatry.wustl.edu
Julie Schweiger, Phone: 314-362-3153, Email: schweigj@psychiatry.wustl.eddu
Dan W. Haupt, MD, Principal Investigator
Additional Information

Click here for the Washington University Department of Psychiatry

Related publications:

Haupt DW, Newcomer JW. Hyperglycemia and antipsychotic medications. J Clin Psychiatry. 2001;62 Suppl 27:15-26; discussion 40-1. Review.

Starting date: December 2004
Last updated: March 10, 2009

Page last updated: August 20, 2015

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