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Determining Metabolic Effects of Valproate and Antipsychotic Therapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167934
First Posted: September 14, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Mental Health (NIMH)
  Purpose
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
Schizophrenia Drug: Valproate Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Valproate and Antipsychotic Therapy

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Oral glucose tolerance test (fsOGTT) and hyperinsulinemic pancreatic clamp [ Time Frame: Measured at baseline and Weeks 6 and 12 ]

Secondary Outcome Measures:
  • Body composition using dual energy x-ray absorptiometry, magnetic resonance scans, and anthropomorphic measurements [ Time Frame: Measured at baseline and Weeks 6 and 12 ]

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
Placebo Comparator: Placebo
50% of participants will receive placebo
Drug: Placebo
Placebo given at same frequency as Valproate
Experimental: Experimental
50% of participants will receive Depakote ER
Drug: Valproate
Depakote ER 500 mg to 3000 mg taken every night
Other Name: Depakote ER

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167934


Contacts
Contact: Martha J. Hessler, BS 314-362-2423 hesslema@psychiatry.wustl.edu
Contact: Julie Schweiger 314-362-3153 schweigj@psychiatry.wustl.edu

Locations
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         
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Dan W. Haupt, MD Washington University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Daniel W. Haupt MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00167934     History of Changes
Other Study ID Numbers: K23MH067795 ( U.S. NIH Grant/Contract )
DAHBR AK-TNET1
First Submitted: September 9, 2005
First Posted: September 14, 2005
Last Update Posted: October 12, 2017
Last Verified: March 2009

Keywords provided by National Institute of Mental Health (NIMH):
Diabetes
Metabolic

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Valproic Acid
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents