Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

NCT00288366 | Completed Results

• 2 other identifiers: 050942NARSAD
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with metabolic levels during treatment with the former medication. The metabolic syndrome is an empirical concept based on extensive evidence that a constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of cancer.

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Keywords

schizophrenia; schizoaffective disorder; bipolar disorder; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• HDL Ratio

  change in HDL ratio after medication switch

  24 weeks from Baseline

Study Arms (2)

1

ACTIVE COMPARATOR

aripiprazole (Abilify)

Drug: ziprasidone vs. aripiprazole; Drug: aripiprazole vs. ziprasidone

2

ACTIVE COMPARATOR

ziprasidone (Geodon)

Drug: aripiprazole vs. ziprasidone

Interventions

ziprasidone vs. aripiprazole DRUG

ziprasidone vs. aripiprazole dosed according to package insert

1

aripiprazole vs. ziprasidone DRUG

aripiprazole vs. ziprasidone dosed according to package insert

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible, patients must :
• Be male or female, age 18-65
• Be diagnosed with schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria
• Be currently receiving antipsychotic drugs (clozapine, haloperidol, olanzapine, quetiapine, or risperidone) (APDs) alone, mood stabilizer(s) (MS) alone, or a combination of the two
• Have a history of compliance with the above medication
• Have presumptive IRS as indicated by a TG/HDL ratio \> 3.5 on current antipsychotic medication
• Be Medicaid eligible or maintain insurance covering requested lab procedures

You may not qualify if:

• A patient will be considered ineligible if he/she:
• Has a diagnosis other than schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria.
• Has a history of noncompliance with prescribed psychiatric medications
• Has a TG/HDL ratio \< 3.5 on current medication
• Is uninsured or is unable to self-pay potential costs of required lab procedures not covered by insurance.
• Is unable to provide written informed consent.
• (Females only) Is pregnant, lactating or plans to become pregnant during study participation

Sponsors & Collaborators

• Northwestern University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator
• Pfizer: collaborator

Study Sites (1)

Psychiatric Hospital at Vanderbilt

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Herbert Y Meltzer
• Organization: Northwestern University

h-meltzer@northwestern.edu

1 312 503 0309

Study Officials

• Yuejin Chen, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 6, 2019
• Results First Posted: August 6, 2019

Record last verified: 2019-07

Locations

US (1)