Clinical trial NCT00288366: Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
Official title: Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Keywords: schizophrenia
schizoaffective disorder
bipolar disorder
metabolic syndrome
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
name: Pfizer
First posted: 2006-02-07
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

-

Primary outcomes:
measure: HDL Ratio
timeFrame: 24 weeks from Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Psychiatric Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Yuejin Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: