N/A
N=49
Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
Schizophrenia · Schizoaffective Disorder · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00288366 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: HDL Ratio — 39.7; 38.4; 43.5; 42.3 unit of Measure ''g/dL''
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ziprasidone vs. aripiprazole (Drug); aripiprazole vs. ziprasidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HDL Ratio |
39.7; 38.4; 43.5; 42.3 | — |
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.
Eligibility Criteria
Inclusion criteria
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
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT00288366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.