An Efficacy and Safety Study of Long Acting Injectable Risperidone and Oral Risperidone in Participants With Schizophrenia or Schizoaffective Disorder

NCT00992407 | Completed Phase 4 Results

• 2 other identifiers: CR015841RISSCH4178
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of long acting injectable (LAI) risperidone and oral risperidone treatment on participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder).

Conditions

Schizophrenia

Keywords

Schizophrenia; Risperidone; Risperdal

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52

  The PSP assesses degree of participant's dysfunction within 4 domains of behavior, socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1=absent to 6=very severe) in each of 4 domains. Based on the 4 domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.

  Baseline and Week 52

Secondary Outcomes (21)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52

  Baseline and Week 52

• Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52

  Baseline and Week 52

• Change From Baseline in Social Functioning Scale (SFS) Score at Week 52

  Baseline and Week 52

• Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52

  Baseline and Week 52

• Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52

  Baseline and Week 52

Study Arms (2)

Risperidone long acting injectables

EXPERIMENTAL

Drug: Risperidone long acting injectables

Risperidone tablets

ACTIVE COMPARATOR

Drug: Risperidone tablets

Interventions

Risperidone long acting injectables DRUG

Risperidone long acting injectables will be administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. A supplementary oral antipsychotic will also be administered for 3-4 weeks after the initial dose of injection.

Also known as: Risperdal Consta

Risperidone long acting injectables

Risperidone tablets DRUG

Risperidone tablets will be administered orally as 0.5-10 mg daily up to Week 52.

Also known as: Risperdal

Risperidone tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (1)

Unknown Facility

Ansan, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Research Director
• Organization: R&D Clinical Research, Seoul KOREA

+82 2 2094 -4518

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: December 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 11, 2014
• Results First Posted: March 11, 2014

Record last verified: 2014-02

Locations

KR (1)