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PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia (PANDORA)

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ClinicalTrials.gov Identifier: NCT00761189
Recruitment Status : Completed
First Posted : September 29, 2008
Results First Posted : March 5, 2014
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone
Enrollment 491
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone
Hide Arm/Group Description Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Period Title: Overall Study
Started 491
Completed 306
Not Completed 185
Reason Not Completed
Adverse Event             42
Lack of Efficacy             45
Lost to Follow-up             36
Withdrawal by Subject             49
Other             13
Arm/Group Title Paliperidone
Hide Arm/Group Description Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Baseline Participants 491
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 491 participants
36.7  (10.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 491 participants
Female
247
  50.3%
Male
244
  49.7%
1.Primary Outcome
Title Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
Hide Description The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 345
Measure Type: Number
Unit of Measure: Percentage of participants
34.78
2.Primary Outcome
Title Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population
Hide Description The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 260
Measure Type: Number
Unit of Measure: Percentage of participants
41.92
3.Secondary Outcome
Title Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population
Hide Description The PSP scale assesses the degree of 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 the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.
Time Frame Baseline, Week 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 49.39  (14.69)
Week 4 59.44  (13.54)
Week 12 62.76  (13.93)
4.Secondary Outcome
Title Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population
Hide Description The PSP scale assesses the degree of 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 the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.
Time Frame Baseline, Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 260
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 49.70  (14.73)
Week 4 60.27  (13.34)
Week 12 64.73  (13.09)
5.Secondary Outcome
Title Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population
Hide Description Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 345
Measure Type: Number
Unit of Measure: Percentage of participants
38.84
6.Secondary Outcome
Title Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population
Hide Description Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 260
Measure Type: Number
Unit of Measure: Percentage of Participants
41.54
7.Secondary Outcome
Title Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population
Hide Description The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Time Frame Baseline, Week 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 343
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline -2.34  (4.78)
Week 4 -3.37  (4.53)
Week 12 -3.57  (4.54)
8.Secondary Outcome
Title Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population
Hide Description The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Time Frame Baseline, Week 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 259
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline -2.39  (4.81)
Week 4 -3.49  (4.53)
Week 12 -4.02  (4.26)
9.Secondary Outcome
Title Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population
Hide Description The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Time Frame Baseline, Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 4.62  (0.70)
Week 2 4.08  (0.81)
Week 4 3.73  (0.87)
Week 8 3.50  (0.91)
Week 12 3.29  (0.98)
10.Secondary Outcome
Title Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population
Hide Description The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Time Frame Baseline, Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 260
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 4.60  (0.68)
Week 2 4.02  (0.81)
Week 4 3.66  (0.85)
Week 8 3.40  (0.87)
Week 12 3.10  (0.91)
11.Secondary Outcome
Title Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
Hide Description The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 345
Measure Type: Number
Unit of Measure: Participants
Very much improved 5
Much improved 115
Minimally Improved 158
No change 46
Minimally worse 15
Much worse 6
Very much worse 0
12.Secondary Outcome
Title Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
Hide Description The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
Overall Number of Participants Analyzed 260
Measure Type: Number
Unit of Measure: Participants
Very much improved 5
Much improved 104
Minimally Improved 118
No change 28
Minimally worse 5
Much worse 0
Very much worse 0
Time Frame Baseline up to Week 12
Adverse Event Reporting Description Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
 
Arm/Group Title Paliperidone
Hide Arm/Group Description Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
All-Cause Mortality
Paliperidone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone
Affected / at Risk (%)
Total   55/491 (11.20%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/491 (0.20%) 
Gastrointestinal disorders   
Gastric Ulcer * 1  1/491 (0.20%) 
Nausea * 1  1/491 (0.20%) 
Vomiting * 1  1/491 (0.20%) 
General disorders   
Chest Discomfort * 1  1/491 (0.20%) 
Hepatobiliary disorders   
Hepatic Steatosis * 1  1/491 (0.20%) 
Hepatotoxicity * 1  1/491 (0.20%) 
Injury, poisoning and procedural complications   
Accidental Overdose * 1  1/491 (0.20%) 
Fall * 1  1/491 (0.20%) 
Lower Limb Fracture * 1  1/491 (0.20%) 
Tendon Injury * 1  1/491 (0.20%) 
Musculoskeletal and connective tissue disorders   
Rhabdomyolysis * 1  1/491 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign Breast Neoplasm * 1  1/491 (0.20%) 
Nervous system disorders   
Dizziness * 1  1/491 (0.20%) 
Dystonia * 1  1/491 (0.20%) 
Headache * 1  2/491 (0.41%) 
Tardive Dyskinesia * 1  1/491 (0.20%) 
Psychiatric disorders   
Abnormal Behaviour * 1  1/491 (0.20%) 
Acute Psychosis * 1  1/491 (0.20%) 
Aggression * 1  5/491 (1.02%) 
Agitation * 1  1/491 (0.20%) 
Alcohol Abuse * 1  1/491 (0.20%) 
Anxiety * 1  4/491 (0.81%) 
Completed Suicide * 1  1/491 (0.20%) 
Delusion * 1  3/491 (0.61%) 
Hallucination * 1  1/491 (0.20%) 
Hallucination, Auditory * 1  3/491 (0.61%) 
Insomnia * 1  1/491 (0.20%) 
Nicotine Dependence * 1  1/491 (0.20%) 
Obsessive Thoughts * 1  1/491 (0.20%) 
Obsessive-Compulsive Disorder * 1  1/491 (0.20%) 
Psychotic Disorder * 1  2/491 (0.41%) 
Schizophrenia * 1  13/491 (2.65%) 
Schizophrenia, Paranoid Type * 1  1/491 (0.20%) 
Social Avoidant Behaviour * 1  3/491 (0.61%) 
Suicidal Ideation * 1  1/491 (0.20%) 
Suicide Attempt * 1  1/491 (0.20%) 
Social circumstances   
Treatment Noncompliance * 1  1/491 (0.20%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Paliperidone
Affected / at Risk (%)
Total   243/491 (49.49%) 
Gastrointestinal disorders   
Constipation * 1  46/491 (9.37%) 
Dry Mouth * 1  49/491 (9.98%) 
Infections and infestations   
Nasopharyngitis * 1  10/491 (2.04%) 
Musculoskeletal and connective tissue disorders   
Muscle Rigidity * 1  30/491 (6.11%) 
Nervous system disorders   
Akathisia * 1  65/491 (13.24%) 
Dizziness * 1  13/491 (2.65%) 
Dizziness Postural * 1  24/491 (4.89%) 
Headache * 1  45/491 (9.16%) 
Sedation * 1  42/491 (8.55%) 
Somnolence * 1  42/491 (8.55%) 
Tremor * 1  35/491 (7.13%) 
Psychiatric disorders   
Insomnia * 1  97/491 (19.76%) 
Reproductive system and breast disorders   
Amenorrhoea * 1  21/491 (4.28%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Clinical Research Associate
Organization: Clinical Research Team, Medical Affairs Korea
Phone: 82-2094-4804
Layout table for additonal information
Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00761189     History of Changes
Other Study ID Numbers: CR015079
PAL-KOR-4001
First Submitted: September 25, 2008
First Posted: September 29, 2008
Results First Submitted: January 22, 2014
Results First Posted: March 5, 2014
Last Update Posted: March 5, 2014