PREvent First Episode Relapse (PREFER)

• Status: Unknown status
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Many patients who have recently received a diagnosis of schizophrenia (e.g., "first-episode schizophrenia") respond very well to their antipsychotic medication when they are acutely ill. Once they are more stable, research has shown that first-episode patients need to remain on their antipsychotic medication. Follow-up studies show that stopping medication prematurely is the most common cause of relapse and readmission. It is important to have new ways to help patients stay stable in the community in order for them to continue on with their rehabilitation and recovery process.

Over the last decade, new antipsychotic medications have been developed that are more effective and have fewer side effects than older antipsychotics. The new medicines are often called "atypical", and were only available by pill or capsule for long-term treatment. Most recently, one of the atypical medications - risperidone - became available as a long-acting injection that can be given once every 2 weeks.

The hypothesis of this study is that patients recovering from an acute episode and who then go on to receive a long-acting version of atypical antipsychotic medication (long-acting risperidone microspheres) will stay on their medications for longer than those who take their atypical medication (any available first-line atypical) in the oral (pill) form.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York - Downstate Medical Center
• Collaborator: Janssen, LP
• Treatments: Antipsychotic Agents; Risperidone

Criteria

There is a 2 step inclusion/exclusion criteria, the first being for assessing overall eligibility to be enter, and then, for continued outpatient treatment for schizophrenia when clinically appropriate.

Inclusion criteria for the first phase:

1. Between 16-50 years of age

2. Psychotic symptoms must have persisted at least one month prior to starting the current antipsychotic

3. Continue to show some positive (psychotic) symptoms of schizophrenia

4. A provisional clinical diagnosis of schizophreniform disorder,schizophrenia, or schizoaffective disorder

5. Confirm that there was no previous history of significant pharmacological treatment with an antipsychotic medication

6. Able to fully participate in the informed consent process

Exclusion criteria for Study Phase I

1. Unable to understand informed consent process

2. A history of nonresponse to, or severe adverse events from, any prior exposure to oral risperidone

3. Will not be living close enough to the medical center to return for follow-up visits or assessments

4. Currently receiving medication over objection by court order

Inclusion criteria for Study Phase II

Key criteria for entry into Study Phase II are:

1. Has clinically responded to the oral antipsychotic regimen

2. Willingness to transition to receive evaluation and future pharmacologic treatment at the Schizophrenia Research Service

3. Has retained capacity to understand the risks and benefits of the maintenance treatment with antipsychotics

4. Willingness to sign informed consent to go into Study Phase II

Exclusion criteria for Study Phase II

1. Has not responded to the current oral antipsychotic regimen, or has had significant side effects to oral risperidone

2. Explicit refusal to even consider the possibility of receiving maintenance antipsychotic by long-acting injection