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

Janssen-Cilag B.V.0 sites0 target enrollmentMarch 22, 2006

Overview

No summary available.

Registry

who.int

Start Date

March 22, 2006

End Date

November 2, 2007

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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.

•\- 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.