Official Title: “Long-Acting Risperidone Treatment for Patients Who Did Not Improve Sufficiently With Treatment During the Preventing Morbidity in First Episode Schizophrenia”

The purpose of this project is to evaluate the efficacy of long-acting risperidone for patients who did not improve sufficiently with the first antipsychotic medication they tried during the Preventing Morbidity in First Episode Schizophrenia study.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

The goal of the proposed pilot study is to investigate the feasibility and efficacy of the long-acting injectable form of the second generation antipsychotic, risperidone, for the treatment of first episode patients who fail to respond to 12 weeks of treatment with the oral preparations of either risperidone, up to 6 mg/day or aripiprazole up to 30 mg/day, in the context of an NIMH-funded trial comparing these two drugs (Preventing Morbidity in First Episode Schizophrenia.) The rationale for using this long-acting medication is that it eliminates covert non-adherence, which may be a factor in poor response. In addition, pharmacokinetic and pharmacodynamic differences between injectable and oral formulations may result in differences in treatment response favoring the injectable form. Subjects who fail to meet criteria for response in the Preventing Morbidity trial will be approached for the proposed long-acting risperidone trial. Risperidone treatment will be open label with titration based upon individual response (within FDA approved dose ranges). Treatment will begin with a phase of supplementation with oral risperidone. Subjects will stop their previous antipsychotic, start 2 mg of oral risperidone per day for one day and then increase the dose to 4 mg per day. Subjects who tolerate one week of oral risperidone will then begin injections of 25 mg long-acting risperidone every 2 weeks for a total of 12 weeks. If clinically indicated, the dose may be increased up to a maximum of 50 mg as per FDA guidelines.

Intervention(s) in this Clinical Trial

• Drug: long-acting injectable risperidone
  • One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.

Primary Measures

• treatment response based upon BPRS and CGI ratings
  • Time Frame: 13 weeks
    Safety Issue?: No
• side effects based upon rating instruments and lab tests
  • Time Frame: 13 weeks
    Safety Issue?: No
• patient acceptance of injections
  • Time Frame: 13 weeks
    Safety Issue?: No

Secondary Measures

• negative symptoms
  • Time Frame: 13 weeks
    Safety Issue?: No

Inclusion Criteria:

• participant in the Preventing Morbidity in First Episode Schizophrenia study current psychotic symptoms competent to provide informed consent

Exclusion Criteria:

• medical contraindications to treatment with long-acting risperidone diabetes
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Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: North Shore Long Island Jewish Health System

Overall Clinical Trial Officials and Contacts

Delbert G Robinson, M.D. Principal Investigator The North Shore-Long Island Jewish Health System  

Overall Contact: Joanne McCormack, M.S.W. 718 470-8446 JMcCorma@lij.edu

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00314327

Study ID Number: 05.04.161

ClinicalTrials.gov Identifier: NCT00314327

Health Authority: United States: Institutional Review Board

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