MedTrace Logo

Different Safety Profile of Risperidone and Paliperidone Extended-release

NCT01284959 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-10-23

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

risperidone

risperidone 3mg, PO, 3 times

DRUG

paliperidone ER

paliperidone ER 6mg, PO,3 times

DRUG

placebo

lactose PO, 3times

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Janssen Korea, Ltd., Korea

    collaborator INDUSTRY

  • Korea Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • Chonbuk National University Hospital

    lead OTHER

Principal Investigators

  • Young-chul Chung, M.D., Ph.D. · Chonbuk National University Hospital

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01284959 on ClinicalTrials.gov