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

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT00345033

Run by

Massachusetts General Hospital

People needed

38

Starts

2005-03-01

Expected to finish

2010-10-01

Last updated by the study team

2014-06-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital Schizophrenia Program — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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