Status:
COMPLETED
Body Mass Index (BMI) and Metabolic Changes Following Switch to Aripiprazole From Olanzapine, Risperidone and Quetiapine
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Brief Summary
Weight gain is a serious, common side effect of many antipsychotic medications. On average, the highest amounts of weight gain are found to occur in people taking clozaril and olanzapine, but with sig...
Detailed Description
Weight gain is a serious, common side effect of many antipsychotic medications. It is a frequent cause of poor adherence to antipsychotic medications and a major contributor to medical problems includ...
Eligibility Criteria
Inclusion
- Any ethnicity
- Antipsychotic monotherapy with olanzapine, risperidone or quetiapine for minimum of 1 month at entry into study and with weight gain of 2 BMI units while on this medication or development of abnormalities of glucose (greater than 110 mg/dl fasting), lipids (total cholesterol \[TC\], high-density lipoprotein \[HDL\], triglycerides \[TG\], or low-density lipoprotein \[LDL\] greater than 10% change) or blood pressure (greater than 20 mmHg change in systolic or diastolic)
- Antipsychotic monotherapy with aripiprazole is planned by the subject's treating psychiatrist.
- Subjects able to fully participate in the informed consent process
- Female subjects of childbearing potential must be using a medically accepted means of contraception which includes tubal ligation, hysterectomy, condoms, oral contraceptives, intrauterine device (IUD), cervical cap, diaphragm, transdermal contraceptive patch, and abstinence.
Exclusion
- Subjects have had a previous trial of aripiprazole
- Serious or unstable medical illness which requires ongoing treatment with medication. This does not include non-insulin dependent diabetes, dyslipidemia or hypertension.
- At serious suicidal risk.
- Subjects with substance abuse or dependence.
- Female subjects who are either pregnant or nursing.
- Known history of mental retardation
Key Trial Info
Start Date :
August 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00312598
Start Date
August 1 2005
End Date
April 1 2010
Last Update
January 13 2014
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