Determining Metabolic Effects of Valproate and Antipsychotic Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00167934
First received: September 9, 2005
Last updated: March 10, 2009
Last verified: March 2009

September 9, 2005
March 10, 2009
December 2004
December 2008   (final data collection date for primary outcome measure)
Oral glucose tolerance test (fsOGTT) and hyperinsulinemic pancreatic clamp [ Time Frame: Measured at baseline and Weeks 6 and 12 ] [ Designated as safety issue: No ]
All subjects will have a 2-hour frequently sampled oral glucose tolerance test (fsOGTT) at baseline, 6-week and 18-week visits. Each subject will have a hyperinsulinemic pancreatic clamp at baseline, 6-week and 18-week visits.
Complete list of historical versions of study NCT00167934 on ClinicalTrials.gov Archive Site
Body composition using dual energy x-ray absorptiometry, magnetic resonance scans, and anthropomorphic measurements [ Time Frame: Measured at baseline and Weeks 6 and 12 ] [ Designated as safety issue: No ]
Body composition using dual energy x-ray absorptiometry, magnetic resonance scans and anthropomorphic measurements are done at baseline, 6-week and 18-week visits
Not Provided
Not Provided
 
Determining Metabolic Effects of Valproate and Antipsychotic Therapy
Metabolic Effects of Valproate and Antipsychotic Therapy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Valproate
    Depakote ER 500 mg to 3000 mg taken every night
    Other Name: Depakote ER
  • Drug: Placebo
    Placebo given at same frequency as Valproate
  • Placebo Comparator: Placebo
    50% of participants will receive placebo
    Intervention: Drug: Placebo
  • Experimental: Experimental
    50% of participants will receive Depakote ER
    Intervention: Drug: Valproate
Haupt DW, Newcomer JW. Hyperglycemia and antipsychotic medications. J Clin Psychiatry. 2001;62 Suppl 27:15-26; discussion 40-1. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Martha J. Hessler, BS 314-362-2423 hesslema@psychiatry.wustl.edu
Contact: Julie Schweiger 314-362-3153 schweigj@psychiatry.wustl.edu
United States
 
NCT00167934
K23 MH067795, DAHBR AK-TNET1
No
Daniel W. Haupt MD, Washington University School of Medicine
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Dan W. Haupt, MD Washington University School of Medicine
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP