A Placebo-Controlled, Cross-Over Trial of Aripiprazole

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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 schizophrenia or schizoaffective disorder. The advantage of the crossover design is that each subject will act as their own control and fewer subjects will be required than a between-group design.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: North Suffolk Mental Health Association
• Collaborator: Eli Lilly and Company
• Treatments: Aripiprazole; Olanzapine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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