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PREvent First Episode Relapse (PREFER)

NCT00220714 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2008-03-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

atypical antipsychotics:oral vs. long-acting route

BEHAVIORAL

Family Psychoeducation

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • State University of New York - Downstate Medical Center

    lead OTHER

Principal Investigators

  • Peter J Weiden, M.D. · State University of New York - Downstate Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Completion
2007-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00220714 on ClinicalTrials.gov