RiSPECT: Risperdal Safety Protocol Evaluation Consta Treatment, a Post Authorization Safety Survey to Obtain Information on the Safety and Efficacy of Risperidone When Used in Routine Clinical Practice.

2014-08-27 03:39:11 | BioPortfolio


The purpose of this research study is to gather information on the safety and efficacy of risperidone when used in routine clinical practice.


This post-authorisation safety survey (PASS) is an international, multicentre, naturalistic, descriptive survey to confirm safety of risperidone in daily practice. This is a single-arm prospective observational survey to compare the safety profile between groups defined by existing risk or disease factors or patient characteristics. The study duration is 6 months with 4 patient visit. The primary objective of this PASS is to confirm safety, as identified in phase III clinical trials of risperidone by collecting data when the drug is used under marketed conditions in routine clinical practice.A secondary objective is to evaluate effectiveness and reasons for initiating risperidone.

RLAI is given as intramuscular injections every 2 weeks. The starting dose of RLAI will be in accordance with the product label (usually 25 mg). If necessary, the dosage of the injection may be increased gradually. Treatment duration is 26 weeks. To ensure continued antipsychotic coverage until the main release of risperidone from the microspheres, previous antipsychotic therapy will be continued concomitantly during the first three weeks of the study.

Study Design

Time Perspective: Prospective


Psychotic Disorders




Janssen Pharmaceutica N.V., Belgium

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:39:11-0400

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Medical and Biotech [MESH] Definitions

Disorders in which the essential feature is a severe disturbance in mood (depression, anxiety, elation, and excitement) accompanied by psychotic symptoms such as delusions, hallucinations, gross impairment in reality testing, etc.

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