CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Risperidonedrug
Likely dose
Risperidone 25 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01855074
NCT01855074Phase 4Completed

Evaluation of Efficacy and Safety of Risperidone in Long-acting Microspheres in Patients With Schizophrenia, Schizophreniform or Schizoaffective Disorders Diagnosed According to the DSM-IV Criteria, After Switching Treatment With Any Antipsychotic Therapy With Long-acting Microspheres of Risperidone

Janssen-Cilag Ltd.·interventional·Posted May 16, 2013·Updated Aug 14, 2013

In Brief

A Phase 4 clinical trial evaluating Risperidone for Schizophrenia and 2 related conditions. Completed, enrolled 80 participants.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of long acting injectable microspheres of risperidone in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), schizophreniform or schizoaffective disorders (disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 16, 2013
Enrollment StartNov 1, 2007
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.1 years ago

Interventions

Risperidonedrug

Risperidone 25 milligram (mg) will be given as intramuscular injection for every 2 weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics will be administered higher doses of risperidone. Doses will be adjusted as per Investigator's discretion.