Phase 4
N=198
Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00320671 ↗Enrolled (actual)
198
Serious AEs
9.6%
Results posted
Aug 2016
Primary outcome: Primary: Percentage of Participants That Responded to Treatment — 62.8; 56.8 percentage of response — p=.61
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aripiprazole (Drug); Risperidone (Drug)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants That Responded to Treatment |
62.8; 56.8 | .61 |
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
Data sourced from ClinicalTrials.gov (NCT00320671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.