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

NCT00320671 | Completed Phase 4 Results DMC

• 1 other identifier: R01MH060004-02
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

First-episode; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorder Not Otherwise Specified NOS; Aripiprazole; Clozapine; Risperidone

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants That Responded to Treatment

  Brief Psychiatric Rating Scale-Anchored (BPRS-A) 4 items on this scale were examined to determine subjects responder status: Items 4. Conceptual Disorganization 8. Grandiosity 12. Hallucinations and 15. Unusual Thought Content. Scores range from-7 (not assessed) to 7 (very severe) Subjects with scores of 3 or less on all 4 items for 2 consecutive visits are deemed responders, subjects with 4 or greater and any of the aforementioned items for 2 consecutive study visits are non responders. Additionally, the subjects response on the Clinical Global Impressions Scale. A Clinical Global Improvement CGI) rating of much or very much improved on 2 consecutive ratings were deemed a responder. Percentages and confidence intervals were used to report response outcome. Response status was assessed throughout the duration of the study; a participant can be deemed a responder any time between weeks 1-week 12. The possible range for this outcome is a score of 4 to 28

  this outcome was assessed throughout the study.

Study Arms (2)

Participants will take aripiprazole

EXPERIMENTAL

Participants will take aripiprazole

Drug: Aripiprazole

Participants will take risperidone

EXPERIMENTAL

Participants will take risperidone

Drug: Risperidone

Interventions

Aripiprazole DRUG

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.

Also known as: Abilify

Participants will take aripiprazole

Risperidone DRUG

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.

Also known as: Risperdal

Participants will take risperidone

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Northwell Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Related Publications (1)

• Robinson DG, Gallego JA, John M, Petrides G, Hassoun Y, Zhang JP, Lopez L, Braga RJ, Sevy SM, Addington J, Kellner CH, Tohen M, Naraine M, Bennett N, Greenberg J, Lencz T, Correll CU, Kane JM, Malhotra AK. A Randomized Comparison of Aripiprazole and Risperidone for the Acute Treatment of First-Episode Schizophrenia and Related Disorders: 3-Month Outcomes. Schizophr Bull. 2015 Nov;41(6):1227-36. doi: 10.1093/schbul/sbv125. Epub 2015 Sep 3.

  PMID: 26338693 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Aripiprazole; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidinones; Pyrimidines

Limitations and Caveats

Metabolic data only capture initial effects and may been impacted by Healthy Lifestyles program neg symptoms are only assessed in the initial context of pos symptoms and may not generalize to neg symptoms in the absence of pos symptoms.

Results Point of Contact

• Title: Delbert Robinson MD
• Organization: Northwell

drobinson@nshs.edu

718.470.8195

Study Officials

• Delbert Robinson, MD

  The North Shore-Long Island Jewish Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Molecular Medicine

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: December 1, 2005
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: September 8, 2016
• Results First Posted: August 31, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)