The RAISE early treatment program for first-episode psychosis: background, rationale, and study design

Abstract

Objective: The premise of the National Institute of Mental Health Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) is to combine state-of-the-art pharmacologic and psychosocial treatments delivered by a well-trained, multidisciplinary team in order to significantly improve the functional outcome and quality of life for first-episode psychosis patients. The study is being conducted in non-academic (ie, real-world) treatment settings, using primarily extant reimbursement mechanisms.

Method: We developed a treatment model and training program based on extensive literature review and expert consultation. Our primary aim is to compare the experimental intervention to "usual care" on quality of life. Secondary aims include comparisons on remission, recovery, and cost-effectiveness. Patients 15-40 years old with a first episode of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or brief psychotic disorder according to DSM-IV and no more than 6 months of treatment with antipsychotic medications were eligible. Patients are followed for a minimum of 2 years, with major assessments conducted by blinded, centralized raters using live, 2-way video. We selected 34 clinical sites in 21 states and utilized cluster randomization to assign 17 sites to the experimental treatment and 17 to usual care. Enrollment began in July 2010 and ended in July 2012 with 404 subjects. The results of the trial will be published separately. The goal of the article is to present both the overall development of the intervention and the design of the clinical trial to evaluate its effectiveness.

Conclusions: We believe that we have succeeded in both designing a multimodal treatment intervention that can be delivered in real-world clinical settings and implementing a controlled clinical trial that can provide the necessary outcome data to determine its impact on the trajectory of early phase schizophrenia.

Trial registration: ClinicalTrials.gov identifier: NCT01321177.

Conflict of interest statement

Potential Conflicts of Interest/Disclosures

Drs. Mueser, Estroff, J Robinson, Penn have nothing to disclose.

Dr. Brunette has received grant support from The National Cancer Institute

Dr. Correll has been a consultant and/or advisor to or has received honoraria from: Actelion, Alexza; Bristol-Myers Squibb, Cephalon, Eli Lilly, Genentech, Gerson Lehrman Group, IntraCellular Therapies, Lundbeck, Medavante, Medscape, Merck, National Institute of Mental Health, Janssen/J&J, Otsuka, Pfizer, ProPhase, Roche, Supernus, Sunovion, Takeda, Teva, and Vanda. He has received grant support from American Academy of Child and Adolescent Psychiatry, BMS, Feinstein Institute for Medical Research, Janssen/J&J, National Institute of Mental Health (NIMH), National Alliance for Research in Schizophrenia and Depression (NARSAD), Novo Nordisk A/S, Otsuka, Thrasher Foundation.

Dr. Kane has been a consultant for Alkermes, Bristol-Myers Squibb, Eli Lilly, EnVivo Pharmaceuticals (Forum), Forest, Genentech, H. Lundbeck. Intracellular Therapeutics, Janssen Pharmaceutica, Johnson and Johnson, Otsuka, Reviva and Roche. Dr. Kane has been on the Speaker’s Bureau for Bristol-Meyers Squibb, Janssen, Genentech and Otsuka. Dr. Kane is a Shareholder in MedAvante, Inc.

Ms. Marcy is a shareholder of Pfizer

Dr. D. Robinson has been a consultant to Asubio and Shire, and he has received grants from Bristol Meyers Squibb, Janssen, and Otsuka.

Dr. Rosenheck has received research support from Janssen Pharmaceutica, and Wyeth Pharmaceuticals. He has been a consultant to Otsuka. He provided expert testimony for the plaintiffs in UFCW Local 1776 and Participating Employers Health and Welfare Fund, et al. v. Eli Lilly and Company; for the respondent in Eli Lilly Canada Inc vs Novapharm Ltd and Minister of Health; for the Patent Medicines Prices

Dr. Schooler has received grant/research support from Otsuka, Neurocrine, and Genentech. She has been on the speaker or advisory board to Lundbeck, Roche, Envivo (Forum) and Sunovion.

© Copyright 2015 Physicians Postgraduate Press, Inc.

Figures

Figure 1

Map of Sites

Figure 2

Study Design