A Placebo-Controlled, Cross-Over Trial of Aripiprazole

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00351936

Run by

North Suffolk Mental Health Association

People needed

16

Starts

2005-12-01

Expected to finish

2007-07-01

Last updated by the study team

2013-02-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Freedom Trail Clinic — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.