Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis

Completed · Phase 4

Conditions studied: Schizophrenia

In brief

This 52 week long study evaluates the effectiveness of aripiprazole versus risperidone in treating people with first-episode schizophrenia. Patients who do not improve with these medications receive clozapine as their third medication trial.

Key facts

Study ID

NCT00320671

Run by

Northwell Health

People needed

198

Starts

2005-12-01

Expected to finish

2015-12-01

Last updated by the study team

2016-09-08

Who can join

Age: 15 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or similar psychotic disorder not otherwise specified, as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P)
• History of previous antipsychotic medication treatment for a duration of 2 weeks or less
• Current positive symptoms rated 4 (moderate) or more on one or more of the following Brief Psychiatric Rating Scale (BPRS-A) items: conceptual disorganization; grandiosity; hallucinatory behavior; or unusual thought content
• Agrees to use an effective form of contraception

You may not qualify if…

• Any serious neurological or endocrine disorder, or any medical condition or treatment known to affect the brain
• Any current medical condition that requires treatment with a medication with psychotropic effects
• At significant risk for suicidal or homicidal behavior
• Cognitive or language limitations, or any other factor that would interfere with a participant's ability to provide informed consent or safely participate in study procedures
• Diagnosis of diabetes, defined as a fasting plasma glucose level of at least 126 mg/dL, or metabolic syndrome, defined as three or more of the following: high blood pressure (greater than 135/85 mmHg); truncal obesity (having a waist circumference greater than 40 inches for men and greater than 35 inches for women); elevated fasting glucose (greater than 110 mg/dL); low HDL-cholesterol (less than 40 mg/dL for men and less than 50 mg/dL for women); or elevated triglycerides (defined as greater than 150 mg/dL)
• Requires treatment with an antidepressant or mood stabilizing medication
• Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features
• Any medical conditions that would make treatment with risperidone or aripiprazole medically inadvisable

Where it is running

• The Zucker Hillside Hospital — Glen Oaks, New York, United States

Full record on ClinicalTrials.gov

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