An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia

NCT00269919 | Completed Phase 4 Results

• 2 other identifiers: CR002089RIS-KOR-64
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Risperidone; Risperidal Consta

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96

  The PANSS is a 30-item scale consisting of 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items) and it is designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 items are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.

  Baseline and Week 96

Secondary Outcomes (13)

• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96

  Baseline and Week 96

• Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96

  Baseline and Week 96

• Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96

  Baseline and Week 96

• Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96

  Baseline and Week 96

• Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96

  Baseline and Week 96

Study Arms (1)

Risperidone Long-Acting Injectable (RLAI)

EXPERIMENTAL

The RLAI 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 2 years.

Drug: Risperidone Long-Acting Injectable (RLAI)

Interventions

Risperidone Long-Acting Injectable (RLAI) DRUG

The RLAI 25 mg or 37.5 mg or 50 mg will be administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.

Risperidone Long-Acting Injectable (RLAI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants diagnosed with schizophrenia or schizoaffective disorder (in-patients or out-patients)
• Participants currently having their symptoms well controlled with a stable dose of oral antipsychotic medication

You may not qualify if:

• Participants who have never received any previous antipsychotic treatment
• Participants who have received clozapine during the last 3 months
• Participants with a serious unstable medical condition, including laboratory abnormalities
• Participants with a history of, or current symptoms of tardive dyskinesia (a complication of neuroleptic therapy involving involuntary movements of facial muscles) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
• Female participants who are pregnant or breast-feeding, or are of childbearing age without adequate contraception

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

There is limitation in the study that selection or observer bias may occur because this clinical trial was an open, non-comparative, single-arm study and precaution would be necessary for interpreting change in various scales observed in this study.

Results Point of Contact

• Title: Medical CRA
• Organization: Janssen Korea Ltd., Korea

+82-2-2094-4804

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: August 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 16, 2014
• Results First Posted: August 9, 2013

Record last verified: 2014-03

Locations

KR (1)