Effects of Atypical Antipsychotic and Valproate Combination Therapy on Glucose and Lipid Metabolism in Schizophrenia

NCT00552500 | Completed

• 2 other identifiers: NARSAD 43625NARSAD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to a) evaluate the effects of haloperidol, olanzapine, and risperidone in combination with valproate on insulin secretion and insulin actions, b) evaluate medication effects on abdominal fat, total body fat and total fat-free mass, and c) evaluate treatment effects on glucose tolerance, lipid profiles, and plasma levels of leptin, adiponectin, ghrelin and C-reactive protein. Hypotheses will be evaluated by measuring 1) insulin action and secretion using frequently sampled intravenous glucose tolerance tests, 2) body composition using dual energy x-ray absorptiometry, magnetic resonance scans, and anthropomorphic measurements, and 3) changes in hormone levels and lipid profiles. The aims will be addressed in non-diabetic schizophrenia patients chronically treated with haloperidol, olanzapine or risperidone who will have valproate added to their treatment. Relevant data is critically needed to target basic research, identify long-term cardiovascular risks, and plan therapeutic interventions.

Conditions

Insulin Resistance; Body Composition

Outcome Measures

Primary Outcomes (1)

• Hypotheses will be evaluated by measuring insulin action and secretion using frequently sampled intravenous glucose tolerance tests

  2 years

Study Arms (1)

Schizophrenics

ACTIVE COMPARATOR

i) meets DSM-IV criteria for schizophrenia, any type, treated with atypical or high potency typical neuroleptics for at least 3 months; ii) aged 18 to 60 years; iii) able to give informed consent; iv) no antipsychotic medication changes for 3 months, and no other medication changes for 2 weeks prior to Baseline Evaluations.

Drug: Depakote (valproate)

Interventions

Depakote (valproate) DRUG

500 mg -2000 mg QD based on individual tolerance and VPA levels

Schizophrenics

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meets DSM-IV criteria for schizophrenia, any type, treated with atypical or high potency typical neuroleptics for at least 3 months
• Aged 18 to 60 years
• Able to give informed consent
• No antipsychotic medication changes for 3 months, and no other medication changes for 2 weeks prior to Baseline Evaluations.

You may not qualify if:

• Meets DSM-IV criteria for the diagnoses of substance abuse or dependence within the past 6 months
• Involuntary legal status (as per Missouri law)
• The presence of any serious medical disorder that may (as confirmed by peer-reviewed literature) confound the assessment of symptoms, relevant biologic measures or diagnosis. The following conditions are currently identified:
• Type 1 diabetes mellitus or symptomatic type 2 diabetes mellitus
• Any intra-abdominal or intrathoracic surgery or limb amputation within the prior 6 months
• Any diagnosed cardiac condition causing documented hemodynamic compromise
• Any diagnosed respiratory condition causing documented or clinically recognized hypoxia
• Pregnancy or high dose estrogens, fever, narcotic therapy, acute sedative hypnotic withdrawal, corticosteroid or spironolactone therapy, dehydration, epilepsy, endocrine disease, high-dose benzodiazepine therapy (\> 25 mg/day of diazepam), or any medical condition known to interfere with glucose utilization
• Meets DSM-IV criteria for Mental Retardation (mild or worse).

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Daniel W Haupt, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2007
• First Posted: November 2, 2007
• Study Start: February 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: June 21, 2018

Record last verified: 2018-06

Locations

US (1)