Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
Completed · Not applicable
Conditions studied: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
In brief
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.
Key facts
- Study ID
- NCT00288366
- Run by
- Northwestern University
- People needed
- 49
- Starts
- 2006-01-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2019-08-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
- Be able to provide written informed consent Exclusion criteria
- 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
Where it is running
- Psychiatric Hospital at Vanderbilt — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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