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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00167934 |
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.
Condition | Intervention |
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Schizophrenia |
Drug: Valproate Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Metabolic Effects of Valproate and Antipsychotic Therapy |
Estimated Enrollment: | 88 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator
50% of participants will receive placebo
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Drug: Placebo
Placebo given at same frequency as Valproate
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Experimental: Experimental
50% of participants will receive Depakote ER
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Drug: Valproate
Depakote ER 500 mg to 3000 mg taken every night
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Martha J. Hessler, BS | 314-362-2423 | hesslema@psychiatry.wustl.edu |
Contact: Julie Schweiger | 314-362-3153 | schweigj@psychiatry.wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Elizabeth T Westerhaus, MA 314-747-1134 westerhe@psychiatry.wustl.edu | |
Contact: Julie Schweiger 314-362-3153 schweigj@psychiatry.wustl.eddu | |
Principal Investigator: Dan W. Haupt, MD |
Principal Investigator: | Dan W. Haupt, MD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Daniel W. Haupt MD ) |
Study ID Numbers: | K23 MH067795, DAHBR AK-TNET1 |
Study First Received: | September 9, 2005 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00167934 |
Health Authority: | United States: Federal Government |
Diabetes Metabolic |
Schizophrenia Mental Disorders Diabetes Mellitus |
Psychotic Disorders Valproic Acid Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antimanic Agents Pharmacologic Actions Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |