Different Safety Profile of Risperidone and Paliperidone Extended-release

NCT01284959 | Completed Phase 4 Results

• 1 other identifier: CBIRB1005-58
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Schizophrenia

Keywords

cognitive function; subjective experiences; neuroleptic-induced deficit syndrome; paliperidone extended-release; risperidone

Outcome Measures

Primary Outcomes (1)

• Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales

  SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) In NIDSS, the average of number 1 to 5 is blunted affect, the average of number 16 to 20 is avolition, the average of number 6 to 15 is cognition, the average of all score is total. Minimum of NIDSS(avolition, blunted affect, cognition, total) is -3, maximum is +3.(subscale score and total) '+' is better outcome, '-' is worse outcome. Minimum of SANS-Global score for alogia and blunted affect is 0, Maximum of SANS-Global score for alogia and blunted affect is 5 The higher number is worse outcome. The zeros are measured and Calcuated value This outcome measure is reporting a change between baseline and 2hr after third medication.

  baseline and 2hr after third medication

Secondary Outcomes (6)

• Assessment of Adverse Events by Objective Rating Scales and Self Report Scales

  baseline and 2hr after third medication

• Assessment of Adverse Events by Objective Rating Scales and Self Report Scales

  baseline and 50hr after third medication

• Assessment of Cognitive Functioning-1

  baseline and 50hr after third medication

• Symptoms Assessment by Objective Rating Scales

  baseline and 50hr after third medication

• Assessment of Cognitive Functioning-2

  baseline and 50hr after third medication

Study Arms (3)

risperidone

EXPERIMENTAL

Drug: risperidone 3mg, PO two times Groups: risperidone

Drug: risperidone

placebo

PLACEBO COMPARATOR

drug: lactose, PO 3 times group: placebo

Drug: placebo

paliperidone ER

EXPERIMENTAL

drug : Paliperidone ER 6mg PO, two times group: paliperidone ER

Drug: paliperidone ER

Interventions

risperidone DRUG

risperidone 3mg, PO, 3 times

Also known as: Rispedal

risperidone

paliperidone ER DRUG

paliperidone ER 6mg, PO,3 times

Also known as: Invega

paliperidone ER

placebo DRUG

lactose PO, 3times

placebo

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead
• AstraZeneca: collaborator
• Janssen Korea, Ltd., Korea: collaborator
• Korea Otsuka Pharmaceutical Co., Ltd.: collaborator
• Sanofi-Synthelabo: collaborator

Study Sites (1)

Chonbuk national university hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone; Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoxazoles; Azoles

Limitations and Caveats

The sample size was small, which presents higher risk of a type II error. The time of assessment after administering placebo or risperidone was noon to 2 PM, which may have contributed to the increased reports of sedation

Results Point of Contact

• Title: Prof. Youngchul Chung
• Organization: Chonbuk National University Hospital

chungyc@chonbuk.ac.kr

+82-63-250-2185

Study Officials

• Young-chul Chung, M.D., Ph.D.

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 27, 2011
• Study Start: June 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 23, 2012
• Results First Posted: October 23, 2012

Record last verified: 2012-09

Locations

KR (1)