Trial Comparing the Effects of Aripiprazole With Those of Standard of Care on Non-HDL Cholesterol in Patients With Schizophrenia or Bipolar I Disorder Who Have Metabolic Syndrome

Last updated: November 7, 2013
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Terminated

Phase

3

Condition

Diabetes Prevention

Schizophrenia And Schizoaffective Disorders (Pediatric)

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT00857818
CN138-564
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study was to determine whether patients with schizophrenia, schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a larger decrease in fasting non-high density lipoprotein (non-HDL) cholesterol levels with aripiprazole than with their current atypical antipsychotic treatment (olanzapine, risperidone, or quetiapine).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Competency in understanding nature of study and ability to sign informed consent form

  • A clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder (manic or mixed) that has been treated with antipsychotics (oral olanzapine,risperidone or quetiapine) for at least 3 months.

  • Treatment with any of the antipsychotic medications olanzapine, risperidone, orquetiapine for at least 3 months

  • A Clinical Global Impression-Severity Scale score of 4 or lower at baseline

  • Confirmed diagnosis of metabolic syndrome

  • Patients not receiving treatment specifically for any of the parameters related tometabolic syndrome at the time of randomization

  • Women of childbearing potential must be using an adequate method of contraception toavoid pregnancy throughout the study and up to 4 weeks after last dose ofinvestigational product

  • Patients for whom it is clinically appropriate to switch from their current atypicalantipsychotic to aripiprazole (determined by the investigator)

Exclusion

Exclusion Criteria:

  • Risk of suicide (suicidal ideation or recently attempted suicide)

  • Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revisioncriteria for any significant psychoactive substance use disorder within 3 months ofscreening

  • Diagnosis of type 1 or 2 diabetes mellitus

  • Current treatment for 1 of the components of metabolic syndrome

  • Use of medication for the purpose of weight loss

  • Diagnosis of bipolar disorders other than bipolar 1, depression with psychoticsymptoms, or organic brain syndromes

  • History of neuroleptic malignant syndrome

  • Diagnosis of Parkinson's disease, Alzheimer's disease, multiple sclerosis, cerebralpalsy, epilepsy, or mental retardation

  • History of seizures

  • Abnormal blood count for platelets, hemoglobin, absolute neutrophils, aspartateaminotransferase, alanine aminotransferase, creatinine, fasting glucose, andthyroid-stimulating hormone

  • Electrocardiogram recording with QTc interval >475 msec

  • Detectable levels of cocaine or positive screen for stimulants or other drugsconsidered (determined by the investigator) to be of abuse or dependence

  • Blood alcohol levels superior or equal to 50 mg/dL [or 10.9 mmol/L]

  • Prior participation in an aripiprazole clinical trial

  • Treatment with aripiprazole within 1 month of enrollment

  • Predefined exclusionary laboratory tests

  • Patients with Bipolar Disorder treated with adjunctive therapy other than a stabledose of mood stabilizers (lithium or valproate) must undergo a 30-day washout periodfor adjunctive therapies, such as antidepressants, prior to randomization.

Study Design

Total Participants: 64
Study Start date:
April 01, 2009
Estimated Completion Date:
March 31, 2010

Connect with a study center

  • Local Institution

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Local Institution

    Pentincton, British Columbia V2A 4M4
    Canada

    Site Not Available

  • Local Institution

    Vancouver, British Columbia V6T 2A1
    Canada

    Site Not Available

  • Local Institution

    Hamilton, Ontario L8N 3K7
    Canada

    Site Not Available

  • Local Institution

    London, Ontario N6H 4V1
    Canada

    Site Not Available

  • Local Institution

    Markham, Ontario L6B 1A1
    Canada

    Site Not Available

  • Local Institution

    Mississauga, Ontario L5M 4N4
    Canada

    Site Not Available

  • Local Institution

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Local Institution

    Montreal, Quebec H3M 3A9
    Canada

    Site Not Available

  • Local Institution

    Quebec, G1R 2W8
    Canada

    Site Not Available

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