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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00269919
First received: December 22, 2005
Last updated: March 25, 2014
Last verified: March 2014
Results First Received: March 29, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Intervention: Drug: Risperidone Long-Acting Injectable (RLAI)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Risperidone Long-acting Injection (RLAI) The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly (into a muscle) depending on Investigator’s discretion every 2 weeks for 2 years.

Participant Flow:   Overall Study
    Risperidone Long-acting Injection (RLAI)  
STARTED     40  
Treated     39  
COMPLETED     13  
NOT COMPLETED     27  
Unspecified                 26  
Started but not treated                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Risperidone Long-acting Injection (RLAI) The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.

Baseline Measures
    Risperidone Long-acting Injection (RLAI)  
Number of Participants  
[units: participants]
  39  
Age  
[units: Years]
Mean ± Standard Deviation
  35.0  ± 8.3  
Gender  
[units: Participants]
 
Female     14  
Male     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96   [ Time Frame: Baseline and Week 96 ]

2.  Secondary:   Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96   [ Time Frame: Baseline and Week 96 ]

3.  Secondary:   Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96   [ Time Frame: Baseline and Week 96 ]

4.  Secondary:   Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96   [ Time Frame: Baseline and Week 96 ]

5.  Secondary:   Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96   [ Time Frame: Baseline and Week 96 ]

6.  Secondary:   Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96   [ Time Frame: Baseline and Week 96 ]

7.  Secondary:   Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96   [ Time Frame: Baseline and Week 96 ]

8.  Secondary:   Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96   [ Time Frame: Baseline and Week 96 ]

9.  Secondary:   Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96   [ Time Frame: Baseline and Week 96 ]

10.  Secondary:   Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96   [ Time Frame: Baseline and Week 96 ]

11.  Secondary:   Change From Baseline in NCFT: TMT-Error at Week 96   [ Time Frame: Baseline and Week 96 ]

12.  Secondary:   Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score   [ Time Frame: Baseline and Week 96 ]

13.  Secondary:   Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96   [ Time Frame: Baseline and Week 96 ]

14.  Secondary:   Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score   [ Time Frame: Baseline and Week 96 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical CRA
Organization: Janssen Korea Ltd., Korea
phone: +82-2-2094-4804


No publications provided


Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00269919     History of Changes
Other Study ID Numbers: CR002089, RIS-KOR-64
Study First Received: December 22, 2005
Results First Received: March 29, 2013
Last Updated: March 25, 2014
Health Authority: Korea: Food and Drug Administration