Status:
COMPLETED
Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Pfizer
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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:
- \-
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00288366
Start Date
January 1 2006
End Date
December 1 2008
Last Update
August 6 2019
Active Locations (1)
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1
Psychiatric Hospital at Vanderbilt
Nashville, Tennessee, United States, 37212