Different Safety Profile of Risperidone and Paliperidone Extended-release

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chonbuk National University Hospital
• Collaborators: AstraZeneca; Janssen Korea, Ltd., Korea; Korea Otsuka Pharmaceutical Co., Ltd.; Sanofi-Synthelabo
• Treatments: Paliperidone Palmitate; Risperidone

Criteria

Inclusion Criteria:

• Aged 18-38 years and meet no DSM-IV diagnostic criteria as assessed by using the Structured Clinical Interview for DSM-IV, research version

Exclusion Criteria:

Anyone who:

• Participated in other clinical trials within 30 days from the start of this clinical trial or is currently participating in one

• Has progressive disease or in unstable medical condition unfit for the trial

• Has been diagnosed in psychiatric terms in the past, depends on psychotropic substance, or has overdosed or depended on the substance or alcohol (except for coffee or tobacco) within 1 month from the trial start

• Is suicidal or highly probable of suicides; OR

• Has test results considered clinically meaningful