PREvent First Episode Relapse (PREFER)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00220714
• Date of registration: 13/09/2005
• Primary sponsor: State University of New York - Downstate Medical Center
• Public title: PREvent First Episode Relapse (PREFER)
• Scientific title: Effectiveness of Long-Acting Risperidone in the Maintenance Treatment of First-Episode Schizophrenia
• Date of first enrolment: November 2004
• Target sample size: 80
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00220714
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Behavioral: Family Psychoeducation

Drug: atypical antipsychotics:oral vs. long-acting route

Primary Outcome(s)

5. Modify and adapt psychoeducational material designed for multiple episode patients to better fit the needs of recently diagnosed patients with schizophrenia.

Compare patient and family attitudes and satisfaction with antipsychotic medication given by long-acting route vs. oral route of drug delivery

Compare the time until the first episode of antipsychotic nonadherence as defined by 2 or more weeks of continuous and intentional cessation of all prescribed antipsychotic medication

Compare the total amount of outpatient days spent adherent to antipsychotic medication as a proportion of outpatient days in the study

Likelihood of accepting a recommendation of long-acting atypical antipsychotic medication

Secondary Outcome(s)

Compare outcome differences between intent-to-treat assignments with actual observed treatment groups

Compare the likelihood of relapse and rehospitalization between long-acting atypical antipsychotic with all available first-line oral atypical agents

Compare the longitudinal course of symptoms and side effects of those remaining on long-acting atypicals to those remaining on oral antipsychotic regimens

Secondary ID(s)

RIS-SCH-420

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen, LP