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Different Safety Profile of Risperidone and Paliperidone Extended-release

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ClinicalTrials.gov Identifier: NCT01284959
Recruitment Status : Completed
First Posted : January 27, 2011
Results First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Sponsor:
Collaborators:
AstraZeneca
Janssen Korea, Ltd., Korea
Korea Otsuka Pharmaceutical Co., Ltd.
Sanofi-Synthelabo
Information provided by (Responsible Party):
Young Chul Chung, Chonbuk National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Condition Schizophrenia
Interventions Drug: risperidone
Drug: paliperidone ER
Drug: placebo
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Risperidone Placebo Paliperidone ER
Hide Arm/Group Description Drug: risperidone Groups: risperidone drug: lactose group: placebo Drug: Paliperidone ER Groups: Paliperidone ER
Period Title: Overall Study
Started 11 12 11
Completed 10 12 10
Not Completed 1 0 1
Reason Not Completed
Withdrawal by Subject             1             0             0
Adverse Event             0             0             1
Arm/Group Title Risperidone Placebo Paliperidone ER Total
Hide Arm/Group Description Drug: risperidone Groups: risperidone drug: lactose group: placebo Drug: Paliperidone ER Groups: Paliperidone ER Total of all reporting groups
Overall Number of Baseline Participants 11 12 11 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 11 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
12
 100.0%
11
 100.0%
34
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 11 participants 34 participants
28.40  (2.59) 28.08  (2.23) 30.60  (3.27) 28.97  (2.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 11 participants 34 participants
Female
7
  63.6%
5
  41.7%
5
  45.5%
17
  50.0%
Male
4
  36.4%
7
  58.3%
6
  54.5%
17
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 11 participants 12 participants 11 participants 34 participants
11 12 11 34
1.Primary Outcome
Title Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales
Hide Description

SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) In NIDSS, the average of number 1 to 5 is blunted affect, the average of number 16 to 20 is avolition, the average of number 6 to 15 is cognition, the average of all score is total.

Minimum of NIDSS(avolition, blunted affect, cognition, total) is -3, maximum is +3.(subscale score and total) '+' is better outcome, '-' is worse outcome. Minimum of SANS-Global score for alogia and blunted affect is 0, Maximum of SANS-Global score for alogia and blunted affect is 5 The higher number is worse outcome. The zeros are measured and Calcuated value This outcome measure is reporting a change between baseline and 2hr after third medication.

Time Frame baseline and 2hr after third medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Risperidone Placebo Paliperidone ER
Hide Arm/Group Description:
Drug: risperidone Groups: risperidone
drug: lactose group: placebo
Drug: Paliperidone ER Groups: Paliperidone ER
Overall Number of Participants Analyzed 10 12 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
NIDSS-Avolition -1.30  (1.22) -0.28  (0.64) -0.66  (0.53)
NIDSS-Blunted Affect -0.70  (0.74) 0.02  (0.35) -0.24  (0.64)
NIDSS-Cognition -0.54  (0.53) 0.02  (0.26) -0.38  (0.39)
NIDSS-Total -0.77  (0.70) -0.06  (0.35) -0.42  (0.38)
SANS-Global score for alogia 0.67  (0.50) 0  (0) 0  (0)
SANS-Global score for blunted affect 0.67  (0.50) 0  (0) 0.10  (0.32)
2.Secondary Outcome
Title Assessment of Adverse Events by Objective Rating Scales and Self Report Scales
Hide Description

DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert–drowsy, muzzy–clear headed, mentally slow–quick witted, attentive–dreamy), physical sedation (strong–feeble, well coordinated–clumsy, lethargic–energetic, incompetent–proficient), tranquilization (calm–excited, contented–discontented, troubled–tranquil, tense–relaxed), and other types of feelings (happy–sad, antagonistic–amicable, interested–bored, withdrawn–gregarious) Minimum of VAS(Mental sedation score,Physical sedation score,Total score) is 0, Maximum is 10.

VAS-total score is average of all subscale scores. Minimum of DIEPSS is 0, Maximum is 4. The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 2hr after third medication.

Time Frame baseline and 2hr after third medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Risperidone Placebo Paliperidone ER
Hide Arm/Group Description:
Drug: risperidone Groups: risperidone
drug: lactose group: placebo
Drug: Paliperidone ER Groups: Paliperidone ER
Overall Number of Participants Analyzed 10 12 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
VAS-Total score 5.41  (1.82) 3.35  (1.69) 4.11  (1.63)
VAS-Mental sedation score 6.05  (2.14) 3.85  (1.82) 4.78  (1.56)
VAS-Physical sedation score 5.78  (1.79) 3.23  (1.66) 4.08  (1.94)
DIEPSS-Bradykinesia score 0.60  (0.52) 0.08  (0.29) 0.20  (0.42)
3.Secondary Outcome
Title Assessment of Adverse Events by Objective Rating Scales and Self Report Scales
Hide Description DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed), and other types of feelings (happy-sad, antagonistic-amicable, interested-bored, withdrawn-gregarious) Minimum of VAS is 0, Maximum is 10 Minimum of DIEPSS is 0, Maximum is 4 The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.
Time Frame baseline and 50hr after third medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Risperidone Placebo Paliperidone ER
Hide Arm/Group Description:
Drug: risperidone Groups: risperidone
drug: lactose group: placebo
Drug: Paliperidone ER Groups: Paliperidone ER
Overall Number of Participants Analyzed 10 12 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
VAS-Total score 6.15  (1.27) 3.74  (1.80) 3.42  (1.75)
VAS-Mental sedation score 6.53  (1.37) 4.21  (1.87) 3.60  (1.83)
VAS-Physical sedation score 6.25  (1.50) 3.69  (1.90) 3.35  (1.85)
DIEPSS-Bradykinesia score 0.25  (0.46) 0  (0) 0.10  (0.32)
4.Secondary Outcome
Title Assessment of Cognitive Functioning-1
Hide Description

CNT(Computerized Neuro-Cognitive Function Test System); The tests included a word fluency test. All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications.

Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome.

Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome.

Minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome.

Minimum of Word-fluency test is 0 and no maximum value, the higher number is better outcome.

The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.

Time Frame baseline and 50hr after third medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Risperidone Placebo Paliperidone ER
Hide Arm/Group Description:
Drug: risperidone Groups: risperidone
drug: lactose group: placebo
Drug: Paliperidone ER Groups: Paliperidone ER
Overall Number of Participants Analyzed 10 12 10
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Word-fluency test-Animal 22.22  (9.46) 25.42  (4.12) 23.50  (6.22)
Word-fluency test-Stationery 22.56  (7.58) 26.00  (5.24) 23.60  (4.70)
Word-fluency test-"ㄱ" 17.44  (7.68) 19.75  (4.54) 17.10  (5.13)
Word-fluency test-"ㅅ" 17.44  (5.85) 18.25  (4.85) 16.40  (2.17)
Word-fluency test-"ㅇ" 16.11  (4.11) 17.17  (4.73) 16.70  (4.27)
5.Secondary Outcome
Title Symptoms Assessment by Objective Rating Scales
Hide Description SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) Minimum of NIDSS is -3, maximum of NIDSS is +3. '+' is better outcome, '-' is worse outcome. Minimum of SNAS-Global score is 0, Maximum of SNAS-Global score is 5 The higher number is worse outcome. The zeros are measured and Calcuated value. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.
Time Frame baseline and 50hr after third medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Risperidone Placebo Paliperidone ER
Hide Arm/Group Description:
Drug: risperidone Groups: risperidone
drug: lactose group: placebo
Drug: Paliperidone ER Groups: Paliperidone ER
Overall Number of Participants Analyzed 10 12 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
NIDSS-Avolition -0.85  (0.70) -0.37  (0.72) 0.14  (0.78)
NIDSS-Blunted Affect -0.70  (0.64) -0.27  (0.34) 0.04  (0.67)
NIDSS-Cognition -0.66  (0.57) -0.26  (0.39) 0.28  (0.61)
NIDSS-Total -0.72  (0.59) -0.29  (0.41) 0.19  (0.63)
SANS-Global score for alogia 0.13  (0.35) 0  (0) 0  (0)
SANS-Global score for blunted affect 0.25  (0.46) 0  (0) 0  (0)
6.Secondary Outcome
Title Assessment of Cognitive Functioning-2
Hide Description

CNT(Computerized Neuro-Cognitive Function Test System); The tests included the Stroop test, Trail-Making Test B (TMT B). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications Minimum of Stroop test is 0, no maximum limit, the higher number is worse outcome.

Minimum of Trail making test B is 0 and no maximum limit, the higher number is worse outcome.

The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.

Time Frame baseline and 50hr after third medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Risperidone Placebo Paliperidone ER
Hide Arm/Group Description:
Drug: risperidone Groups: risperidone
drug: lactose group: placebo
Drug: Paliperidone ER Groups: Paliperidone ER
Overall Number of Participants Analyzed 10 12 10
Mean (Standard Deviation)
Unit of Measure: milliseconds
Stroop test-Color 15.40  (4.51) 13.09  (1.67) 12.68  (1.70)
Stroop test-Word-color 21.84  (4.53) 17.53  (2.97) 18.31  (3.29)
Stroop test-Interference score 6.43  (1.77) 4.44  (2.01) 5.63  (2.71)
Trail making test B 29.78  (10.24) 28.42  (7.45) 31.10  (8.66)
7.Secondary Outcome
Title Assessment of Cognitive Functioning-3
Hide Description

CNT(Computerized Neuro-Cognitive Function Test System); The tests included Wisconsin Card-Sorting Test (WCST). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications.

Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome.

Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome.

Minimum of Wisconsin card sorting test-Trials to complete first category trials is 0, Maximum is 128 and minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome.

The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after th

Time Frame baseline and 50hr after third medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Risperidone Placebo Paliperidone ER
Hide Arm/Group Description:
Drug: risperidone Groups: risperidone
drug: lactose group: placebo
Drug: Paliperidone ER Groups: Paliperidone ER
Overall Number of Participants Analyzed 10 12 10
Mean (Standard Deviation)
Unit of Measure: trials
Wisconsin card sorting test-Category completed 6.00  (0.00) 6.00  (0.00) 6.00  (0.00)
Wisconsin card sorting test-Perseverative response 14.11  (6.03) 13.08  (8.11) 10.10  (2.96)
Wisconsin card sorting test-Perseverative error 10.00  (3.50) 9.67  (6.11) 6.50  (1.18)
WCST-Trials to complete first category trials 14.00  (7.98) 11.75  (2.01) 12.10  (2.42)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Risperidone Placebo Paliperidone ER
Hide Arm/Group Description Drug: risperidone Groups: risperidone drug: lactose group: placebo Drug: Paliperidone ER Groups: Paliperidone ER
All-Cause Mortality
Risperidone Placebo Paliperidone ER
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Risperidone Placebo Paliperidone ER
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/11 (18.18%)      0/12 (0.00%)      0/11 (0.00%)    
Gastrointestinal disorders       
Abdominal discomfort(vomiting) *  1/11 (9.09%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
Nervous system disorders       
sedation *  1/11 (9.09%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Risperidone Placebo Paliperidone ER
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/11 (45.45%)      2/12 (16.67%)      0/11 (0.00%)    
Gastrointestinal disorders       
sedation   5/11 (45.45%)  5 2/12 (16.67%)  2 0/11 (0.00%)  0
abdominal discomfort   2/11 (18.18%)  2 1/12 (8.33%)  1 0/11 (0.00%)  0
Nervous system disorders       
dizziness   2/11 (18.18%)  2 0/12 (0.00%)  0 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
The sample size was small, which presents higher risk of a type II error. The time of assessment after administering placebo or risperidone was noon to 2 PM, which may have contributed to the increased reports of sedation
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: Prof. Youngchul Chung
Organization: Chonbuk National University Hospital
Phone: +82-63-250-2185
Responsible Party: Young Chul Chung, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01284959     History of Changes
Other Study ID Numbers: CBIRB1005-58
First Submitted: January 25, 2011
First Posted: January 27, 2011
Results First Submitted: February 29, 2012
Results First Posted: October 23, 2012
Last Update Posted: October 23, 2012