Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effects of combination treatment with aripiprazole and clozapine on insulin resistance, blood fat levels, and weight gain in people diagnosed with schizophrenia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Aripiprazole; Clozapine

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia (any subtype) or schizoaffective disorder (any subtype)

• Treatment with clozapine for at least 1 year

• Stable dose of clozapine for at least 1 month

• Well established compliance with outpatient medications

• Female participants of non-childbearing potential or of childbearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study

Exclusion Criteria:

• Current substance abuse

• Psychiatrically unstable

• Significant medical illness, including severe cardiovascular, hepatic, or renal disease

• History of immunosuppression

• Current or recent radiation or chemotherapy treatment for cancer

• Chronic use of steroids

• Pregnant or breastfeeding