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Determining Metabolic Effects of Valproate and Antipsychotic Therapy

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The Washington University

Status

Completed

Conditions

Schizophrenia

Treatments

Drug: Placebo
Drug: Valproate

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00167934
DAHBR AK-TNET1
K23MH067795 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

164 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

164 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
50% of participants will receive placebo
Treatment:
Drug: Placebo
Experimental
Experimental group
Description:
50% of participants will receive Depakote ER
Treatment:
Drug: Valproate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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