Is premorbid functioning a predictor of outcome in patients with early onset psychosis treated with Risperdal Consta? - PROPEL Study

• Conditions: Schizophrenia

• Registration Number: EUCTR2005-004621-25-BE
• Lead Sponsor: Janssen-Cilag EMEA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-04
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- Male or female

- Age >18 years

- Primary diagnosis of schizophrenia/schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV-TR).

- Primary diagnosis for less than 2 years following initial diagnosis and treatment.

- At least 2 previous psychotic episodes.

- Maximum total PANSS score of 80.

- Patients who, in the opinion of the investigator, require at least 6 months treatment with antipsychotic medication.

- Patients may be currently treated with any antipsychotic (with the exception of clozapine and depot neuroleptics) at doses not exceeding the registered highest recommended dose.

- Female patients must be surgically sterile, or practicing an effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, intra-uterine device, double-barrier method, contraceptive patch, male partner sterilization or abstinence) before entry and throughout the study; and have a negative pregnancy test at baseline, before study entry.

- Patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- DSM-IV-TR Axis I diagnosis other than schizophrenia or schizoaffective disorder.

- Patients already on treatment with Risperdal Consta.

- Patients requiring treatment at entry with mood stabilizers or antidepressants may enter the study only if a stable dose has been received for 3 months prior to study entry.

- Pregnant or breast-feeding females.

- Patients who have previously received treatment with clozapine.

- Evidence of alcohol or drug dependence (except for nicotine and caffeine dependence according to DSM-IV-TR criteria diagnosed in the last month prior to entry).

- History of severe drug allergy, drug hypersensitivity or neuroleptic malignant syndrome.

- Known hypersensitivity/intolerance or previous non-response to oral risperidone proven by adequate drug plasma levels (non-responders due to non-compliance are not excluded).

- Patients who are known non-responders to previous treatment with at least 2 antipsychotics.

- Serious, unstable and untreated medical illnesses.

- Patients with conditions and symptoms that are listed in the SmPC under special warnings and special precautions for use.

- Patients with mental retardation.

- Known clinically significant ECG abnormality.

- Patients at acute risk of suicide in the investigators opinion at study entry or history of suicidal attempt(s) in the last 3 months before the
study entry.

- Patients having received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.

- Patients with known phenylketonuria.

- Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test the hypothesis that patients with good premorbid functioning, as assessed using the Premorbid Adjustment Scale, will respond better to treatment as measured by changes from baseline on the PANSS total score and CGI-S than patients with poor premorbid functioning.;Secondary Objective: (a) to assess the effectiveness, safety, tolerability, and functioning of patients in the early phase of psychosis who are treated with of Risperdal Consta as<br>follows:<br>Effectiveness: via CGI-S/C, PANSS, retention rate<br>Functioning: (SF-36); rehospitalisation rates<br>Safety and tolerability: via reported adverse events, ESRS and retention rate<br><br>(b) Examine whether greater insight, as measured by the SAI-E and PANSS, is positively associated with better outcomes;Primary end point(s): Clinical Response (improvement) rate defined as >=20% improvement on PANSS total score from baseline to endpoint.