Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00946985
Recruitment Status : Terminated (The recruitment rate for the study was inadequate to achieve its enrollment goals.)
First Posted : July 27, 2009
Results First Posted : July 16, 2012
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):
Ortho-McNeil Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Schizophrenia
Interventions Drug: paliperidone palmitate
Drug: oral risperidone
Enrollment 163
Recruitment Details This trial was intended to recruit patients from multiple sites in North America, Europe, and Asia.
Pre-assignment Details Eligible patients were to be treated with paliperdione palmitate for up to 25 weeks (stabilization phase). Patients meeting stabilization criteria were to be randomized to either paliperidone palmitate or oral risperidone and be treated for 24 months (relapse prevention phase).
Arm/Group Title Paliperidone Palmitate
Hide Arm/Group Description 50, 75, 100, or 150 mg equivalent (eq.) monthly injection
Period Title: Stabilization Phase (25 Weeks)
Started 162
Completed 2
Not Completed 160
Reason Not Completed
Adverse Event             4
Lack of Efficacy             3
Lost to Follow-up             5
Withdrawal by Subject             4
Study Closed by Sponsor             139
Failed to Meet Stability Criteria             2
Prohibited Medication During Study             1
Patient Moved Away             2
Period Title: Relapse Prevention Phase (24 Months)
Started 2 [1]
Completed 0
Not Completed 2
Reason Not Completed
Study Closed by Sponsor             2
[1]
Both randomized patients were discontinued when the sponsor terminated the trial early.
Arm/Group Title Paliperidone Palmitate
Hide Arm/Group Description 50, 75, 100, or 150 mg equivalent (eq.) monthly injection
Overall Number of Baseline Participants 162
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants
27  (4.55)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 162 participants
18-23 years 46
24-29 years 62
30-35 years 54
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
Female
54
  33.3%
Male
108
  66.7%
Positive and Negative Syndrome Scale (PANSS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 162 participants
85.9  (13.65)
[1]
Measure Description: Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Scores for PANSS positive and negative each range from 7 to 49. Scores for General Psychopathology range from 16 to 112. The sum of all 30 items is defined as the PANSS total score and ranges from 30 to 210.
Clinical Global Impression of Severity (CGI-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 162 participants
4.4  (0.56)
[1]
Measure Description: The Clinical Global Impression - Severity of Illness (CGI-S) is a clinician-rated subscale (low=0, high=7, higher score indicates increasing illness). The clinician rates the severity of symptoms in relation to the clinician's total experience with schizophrenia subjects using a 7-point scale (1=normal, not at all ill, 2= borderline ill, 3= mildly ill, 4=moderately ill, 5= markedly ill, 6= severely ill, 7= among the most extremely ill subjects) in response to the question "Considering your total clinical experience with this particular population, how ill is the subject at this time?".
Age at First Diagnosis of Schizophrenia  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants
24.1  (4.61)
Current Schizophrenia Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 162 participants
Paranoid (295.30) 142
Disorganized (295.10) 6
Undifferentiated (295.90) 13
Residual (295.60) 1
[1]
Measure Description: Per the Diagnostic and Statistical Manual for Mental Disorders fourth edition (DSM-IV) criteria.
1.Primary Outcome
Title Time to Relapse During Relapse Prevention Phase
Hide Description Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was to include all randomized patients who took at least one dose of study medication (ITT population). However, due to early study termination, only 2 patients were randomized and they did not have sufficient follow up. Hence the planned efficacy analysis could not be carried out.
Arm/Group Title Paliperidone Palmitate
Hide Arm/Group Description:
50, 75, 100, or 150 mg equivalent (eq.) monthly injection
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone Palmitate
Hide Arm/Group Description 50, 75, 100, or 150 mg equivalent (eq.) monthly injection
All-Cause Mortality
Paliperidone Palmitate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone Palmitate
Affected / at Risk (%)
Total   6/162 (3.70%) 
Injury, poisoning and procedural complications   
Hand Fracture * 1  1/162 (0.62%) 
Psychiatric disorders   
Schizophrenia * 1  4/162 (2.47%) 
Aggression * 1  1/162 (0.62%) 
Depression * 1  1/162 (0.62%) 
Self Injurious Behaviour * 1  1/162 (0.62%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Paliperidone Palmitate
Affected / at Risk (%)
Total   50/162 (30.86%) 
General disorders   
Injection Site Pain * 1  10/162 (6.17%) 
Investigations   
Weight Increased * 1  8/162 (4.94%) 
Musculoskeletal and connective tissue disorders   
Pain in Extremity * 1  5/162 (3.09%) 
Nervous system disorders   
Headache * 1  8/162 (4.94%) 
Tremor * 1  8/162 (4.94%) 
Akathisia * 1  5/162 (3.09%) 
Psychiatric disorders   
Insomnia * 1  10/162 (6.17%) 
Agitation * 1  8/162 (4.94%) 
Anxiety * 1  8/162 (4.94%) 
Restlessness * 1  4/162 (2.47%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, 12.1
No efficacy analysis was performed due to early termination of the study (only 2 patients were randomized at the time of study termination).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Clinical Project Scientist
Organization: Ortho-McNeil Janssen Scientific Affairs, LLC
Phone: 609-730-3229
Responsible Party: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00946985     History of Changes
Other Study ID Numbers: CR015646
R092670SCH3004 ( Other Identifier: Ortho-McNeil Janssen Scientific Affairs, LLC )
First Submitted: July 2, 2009
First Posted: July 27, 2009
Results First Submitted: March 8, 2011
Results First Posted: July 16, 2012
Last Update Posted: September 10, 2012