Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier:
NCT01726335
First received: November 9, 2012
Last updated: April 10, 2014
Last verified: April 2014
Results First Received: April 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Risperidone prolonged release

  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 Prolonged Release Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.

Participant Flow:   Overall Study
    Risperidone Prolonged Release  
STARTED     53  
COMPLETED     29  
NOT COMPLETED     24  
Lost to Follow-up                 2  
Withdrawal by Subject                 15  
Adverse Event                 4  
Lost to Follow-up                 2  
Exacerbation of psychotic symptoms                 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 Prolonged Release Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.

Baseline Measures
    Risperidone Prolonged Release  
Number of Participants  
[units: participants]
  53  
Age  
[units: Years]
Mean ± Standard Deviation
  33.6  ± 9.1  
Gender  
[units: Participants]
 
Female     14  
Male     39  
Positive and Negative Syndromes Scale (PANSS) Total Score [1]
[units: Units on a scale]
Mean ± Standard Deviation
  58.80  ± 1.82  
[1] The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2   [ Time Frame: Week 2 ]

2.  Primary:   Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4   [ Time Frame: Week 4 ]

3.  Primary:   Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8   [ Time Frame: Week 8 ]

4.  Primary:   Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16   [ Time Frame: Week 16 ]

5.  Primary:   Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24   [ Time Frame: Week 24 ]

6.  Primary:   Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38   [ Time Frame: Week 38 ]

7.  Primary:   Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50   [ Time Frame: Week 50 ]

8.  Secondary:   Clinical Global Impressions (CGI) - Disease Severity Score   [ Time Frame: Baseline and Week 2, 4, 8, 16, 24, 38 and 50 ]

9.  Secondary:   Extrapyramidal Symptoms Rating Scale (ESRS) Total Score   [ Time Frame: Baseline and Week 2, 4, 8, 16, 24 and 50 ]

10.  Secondary:   Drug Attitude Inventory (DAI-10)   [ Time Frame: Screening, and Week 8, 24 and 50 ]

11.  Secondary:   Short Form-36 (SF-36) - Quality of Life   [ Time Frame: Baseline and Week 50 ]

12.  Secondary:   Personal and Social Performance (PSP) Scale Score   [ Time Frame: Screening, and Week 8, 16, 24, 38 and 50 ]

13.  Secondary:   Global Assessment of Functioning (GAF) Scale Score   [ Time Frame: Screening, and Week 8, 16, 24, 38 and 50 ]


  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
No text entered.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Medical Group Manager
Organization: Janssen-Cilag Ltd.
phone: +55 11 30302738


No publications provided


Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT01726335     History of Changes
Other Study ID Numbers: CR012484, RISSCH4135
Study First Received: November 9, 2012
Results First Received: April 18, 2013
Last Updated: April 10, 2014
Health Authority: Brazil: Ethics Committee