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Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome


N/A
18 Years
65 Years
Not Enrolling
Both
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

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Trial Information

Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

Inclusion 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:

-

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

change in TG/HDL ratio after medication switch

Outcome Time Frame:

twelve months

Safety Issue:

Yes

Principal Investigator

Yuejin Chen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt University

Authority:

United States: Food and Drug Administration

Study ID:

050942

NCT ID:

NCT00288366

Start Date:

January 2006

Completion Date:

December 2008

Related Keywords:

  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder
  • schizophrenia
  • schizoaffective disorder
  • bipolar disorder
  • metabolic syndrome
  • Bipolar Disorder
  • Insulin Resistance
  • Metabolic Syndrome X
  • Psychotic Disorders
  • Schizophrenia

Name

Location

Psychiatric Hospital at VanderbiltNashville, Tennessee  37212