Status:
COMPLETED
A Placebo-Controlled, Cross-Over Trial of Aripiprazole
Lead Sponsor:
North Suffolk Mental Health Association
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated patients with schiz...
Detailed Description
Specific Aims: This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated pat...
Eligibility Criteria
Inclusion
- Male or female
- Age 18-65
- Diagnosis of schizophrenia, any subtype, or schizoaffective disorder, any sub-type
- Body mass index \> 30 Kg/m2 or \>27 Kg/m2 with other risk factors (HTN, Lipid abnormalities)
- Well established compliance with outpatient medications.
- Maintained on a stable dose of olanzapine for at least one month.
Exclusion
- Serious medical or neurological illness (unstable cardiac disease, malignancy, liver or renal impairment, etc.)
- Current substance abuse
- Psychiatrically unstable, which is defined as a score on the CGI's severity of illness question of 5 or greater or a baseline Total PANSS score \> 75
- Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
- Serious suicidal or homicidal risk within the past three months
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00351936
Start Date
December 1 2005
End Date
July 1 2007
Last Update
February 4 2013
Active Locations (1)
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1
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114