CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
risperidone +2 moredrug
Likely dose
risperidone 3mgfrom 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/NCT01284959
NCT01284959Phase 4Completed
CompareCT.gov

Different Safety Profile of Risperidone and Paliperidone Extended-release: a Double-blind, Placebo-controlled Trial With Healthy Volunteers

Chonbuk National University Hospital·interventional·Posted Jan 27, 2011·Updated Oct 23, 2012

In Brief

A Phase 4 clinical trial evaluating risperidone, paliperidone ER, and 1 other intervention for Schizophrenia. Completed, enrolled 34 participants across 1 site.

Detailed Summary

The main objective of this study was to assess subjective experiences related to secondary negative symptoms and cognitive performance in healthy volunteers in response to multiple doses of paliperidone ER and risperidone in a double-blind, placebo-controlled trial. Adverse events caused by these drugs were also evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesSouth Korea
CollaboratorsAstraZeneca, Janssen Korea, Ltd., Korea, Korea Otsuka Pharmaceutical Co., Ltd., Sanofi-Synthelabo

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 27, 2011
Enrollment StartJun 1, 2010
Primary CompletionJul 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.4 years ago

Interventions

risperidonedrug

risperidone 3mg, PO, 3 times

paliperidone ERdrug

paliperidone ER 6mg, PO,3 times

placebodrug

lactose PO, 3times