NCT00314327

Optimizing Response in Psychosis Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 15 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this project is to evaluate the efficacy of long-acting risperidone for patients with first episode schizophrenia spectrum who did not improve sufficiently with the first antipsychotic medication they tried during their initial treatment trial.

Detailed description

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 an oral antipsychotic. 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 have not responded sufficiently to treatment with an antipsychotic 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.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorder
• Psychotic Disorder Not Otherwise Specified

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-04-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2006-04-13
• Last updated: 2018-05-16
• Results posted: 2015-04-29

Locations

2 sites across 1 country: United States