Status:
TERMINATED
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
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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-h...
Eligibility Criteria
Inclusion
- 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, or quetiapine 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 to metabolic syndrome at the time of randomization
- Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and up to 4 weeks after last dose of investigational product
- Patients for whom it is clinically appropriate to switch from their current atypical antipsychotic to aripiprazole (determined by the investigator)
Exclusion
- Risk of suicide (suicidal ideation or recently attempted suicide)
- Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision criteria for any significant psychoactive substance use disorder within 3 months of screening
- 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 psychotic symptoms, or organic brain syndromes
- History of neuroleptic malignant syndrome
- Diagnosis of Parkinson's disease, Alzheimer's disease, multiple sclerosis, cerebral palsy, epilepsy, or mental retardation
- History of seizures
- Abnormal blood count for platelets, hemoglobin, absolute neutrophils, aspartate aminotransferase, alanine aminotransferase, creatinine, fasting glucose, and thyroid-stimulating hormone
- Electrocardiogram recording with QTc interval \>475 msec
- Detectable levels of cocaine or positive screen for stimulants or other drugs considered (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 stable dose of mood stabilizers (lithium or valproate) must undergo a 30-day washout period for adjunctive therapies, such as antidepressants, prior to randomization.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00857818
Start Date
April 1 2009
End Date
March 1 2010
Last Update
December 2 2013
Active Locations (14)
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1
Local Institution
Calgary, Alberta, Canada, T2N 2T9
2
Local Institution
Pentincton, British Columbia, Canada, V2A 4M4
3
Local Institution
Vancouver, British Columbia, Canada, V6T 2A1
4
Local Institution
Hamilton, Ontario, Canada, L8N 3K7