Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole; Risperidone
Intervention description: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.; The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
Intervention MeSH terms: Risperidone; Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 15 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: First-episode; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorder Not Otherwise Specified NOS; Aripiprazole; Clozapine; Risperidone

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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