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

NCT00320671 ↗

Phase 4 Completed 198 enrolled Northwell Health National Institute of Mental Health (NIMH) · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2005-12
Primary completion: 2014-12
Completion: 2015-12

Outcome

Missed primary endpoint

registry analysis (non-inferiority or equivalence test); Percentage of Participants That Reposonded to Aripiprazole; p = .61; Cumulative Response Rates 62.8 (95% CI 50.8 to 74.8); Log Rank NCT00320671 ↗

paper Positive symptom response rates did not differ (62.8% vs 56.8%) nor did time to response. PMID 26338693 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aripiprazole	Other / unclassified	5 mg	Oral
Subject	Aripiprazole	Other / unclassified	30 mg	Oral
Subject	Risperidone	Other / unclassified	1 mg	Oral
Subject	Risperidone	Other / unclassified	6 mg	Oral