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A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder

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ClinicalTrials.gov Identifier: NCT01193153
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : January 5, 2015
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Schizoaffective Disorder
Interventions Drug: Placebo
Drug: paliperidone palmitate
Enrollment 667
Recruitment Details  
Pre-assignment Details Participants without previous exposure to paliperidone extended-release (ER) (Invega), or risperidone, received paliperidone ER 6 milligram (mg)/day for 4 to 6 days (during Screening) to test oral tolerability. Only participants, who had ability to tolerate the drug, as judged by treating physician, were eligible for enrollment in the study.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period. DB Relapse prevention period (15 months): Same dose as Day 92 once every 4 weeks until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment. Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks during double-blind relapse prevention period.
Period Title: Open-label Lead in Period
Started 667 0
Completed 432 0
Not Completed 235 0
Reason Not Completed
Lost to Follow-up             32             0
Pregnancy             1             0
Withdrawal by Subject             69             0
> 6 Weeks Between 2 Study Drug             4             0
Other             14             0
Subject Failed Stabilization Criteria             47             0
Adverse Event             41             0
Death             1             0
Lack of Efficacy             26             0
Period Title: Open-label Stabilization Period
Started 432 0
Completed 334 0
Not Completed 98 0
Reason Not Completed
Adverse Event             9             0
Death             2             0
Lost to Follow-up             10             0
Lack of Efficacy             5             0
Withdrawal by Subject             29             0
Subject Failed Stabilization Criteria             35             0
Other             8             0
Period Title: Double Blind Relapse Prevention Period
Started 164 170
Completed 100 65
Not Completed 64 105
Reason Not Completed
Other             2             3
Adverse Event             12             3
Death             2             0
Lost to Follow-up             2             9
Pregnancy             1             0
Withdrawal by Subject             19             30
Experienced Relapse             25             57
> 6 Weeks Between 2 Study Drug             1             3
Arm/Group Title Entire Study Population
Hide Arm/Group Description Included all participants who received at least 1 dose of paliperidone palmitate in open-label lead in period.
Overall Number of Baseline Participants 667
Hide Baseline Analysis Population Description
Open-label (OL) intent-to-treat (ITT) analysis set included all participants who received at least 1 injection of open-label study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 667 participants
39.5  (10.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 667 participants
Female
310
  46.5%
Male
357
  53.5%
1.Primary Outcome
Title Double-blind: Percentage of Participants Who Experienced Relapse
Hide Description Relapse was defined as first occurrence of any 1 of following:psychiatric hospitalization due to worsening symptoms; any intervention employed to avert imminent hospitalization due to worsening symptoms or need for additional antipsychotic,antidepressants/mood stabilizing medication; deliberate self-injury,suicidal/homicidal ideation that is clinically significant as determined by investigator,or violent behavior resulting in clinically significant injury to another person or property damage; worsening of any 1 or more of 8 selected positive and negative syndrome scale(PANSS) items to a score of greater than or equal to (>= 6) after randomization(if the score for the corresponding item was less than or equal to [<=] 4 at randomization); worsening of certain other measures in specific ways at 2 consecutive visits. Relapse by subgroup of participants on monotherapy,adjunctive therapy to antidepressants/mood stabilizers,participants with psychotic symptoms/mood symptoms was examined.
Time Frame Day 1 up to Month 15 of double blind relapse prevention period
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind(DB) Intent-to-Treat(ITT) analysis set included all randomly assigned participants who received at least 1 injection of DB study medication.‘n’ signifies participants who were evaluable for each specified category,for each arm.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Overall Number of Participants Analyzed 164 170
Measure Type: Number
Unit of Measure: percentage of participants
All Participants (n=164, 170) 15.2 33.5
Monotherapy subset (n=78, 73) 11.5 32.9
Adjunct therapy subset (n=86, 97) 18.6 34.0
Psychotic Symptoms (n=164, 170) 12.8 31.2
Mood Symptoms;Any Mood Symptoms (n=164, 170) 11.0 28.2
Mood Symptoms;Manic (n=164, 170) 3.0 9.4
Mood Symptoms;Depressive (n=164, 170) 4.9 13.5
Mood Symptoms; Mixed (n=164, 170) 3.0 5.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate, Placebo
Comments All participants: p-value was calculated using log-rank test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.49
Confidence Interval (2-Sided) 95%
1.55 to 3.99
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate, Placebo
Comments Monotherapy subset: Hazard ratio and corresponding p-value, and 95% Confidence Interval (CI) were calculated from Cox proportional hazard regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.38
Confidence Interval (2-Sided) 95%
1.57 to 7.28
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate, Placebo
Comments Adjunct therapy subset: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.03
Confidence Interval (2-Sided) 95%
1.11 to 3.68
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate, Placebo
Comments Psychotic Symptoms: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.82
Confidence Interval (2-Sided) 95%
1.70 to 4.67
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate, Placebo
Comments Mood Symptoms (Any Mood Symptoms):Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.93
Confidence Interval (2-Sided) 95%
1.70 to 5.04
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate, Placebo
Comments Mood Symptoms (Manic): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.62
Confidence Interval (2-Sided) 95%
1.32 to 9.89
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate, Placebo
Comments Mood Symptoms (Depressive): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.12
Confidence Interval (2-Sided) 95%
1.39 to 6.98
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate, Placebo
Comments Mood Symptoms (Mixed): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.238
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.93
Confidence Interval (2-Sided) 95%
0.65 to 5.78
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Total Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA])
Hide Description The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.
Time Frame Baseline and Week 64 of double blind relapse prevention period
Hide Outcome Measure Data
Hide Analysis Population Description
DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Overall Number of Participants Analyzed 164 170
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Baseline (n=164, 170) 72.8  (0.81) 74.5  (0.81)
Change at Week 64 (n=98, 65) 2.0  (0.92) -1.3  (1.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate, Placebo
Comments The null hypothesis is that there is no difference in the mean of the PSP total score between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments P-value based on change from DB baseline in PSP score and was analyzed using mixed-model repeated measures analysis of covariance based on observed data; within-participant repeated measures were modeled using an unstructured covariance matrix.
Method MMRM ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
0.68 to 5.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.33
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint
Hide Description The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.
Time Frame Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
Hide Outcome Measure Data
Hide Analysis Population Description
OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. Last Observation Carried Forward (LOCF) method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Participants did not receive placebo during open-label lead in period and open-label stabilization period.
Overall Number of Participants Analyzed 667 0
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
OL Lead-in Period:Baseline (n=667) 51.4  (11.02)
OL Lead-in Period:Change at Endpoint (n=622) 12.6  (13.71)
OL Stabilization Period:Change at Endpoint (n=622) 13.8  (14.92)
4.Secondary Outcome
Title Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint
Hide Description The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.
Time Frame Baseline and Endpoint (Week 64/LOCF) in double-blind period
Hide Outcome Measure Data
Hide Analysis Population Description
DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Overall Number of Participants Analyzed 164 170
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
Double-blind: Baseline (n=164, 170) 74.5  (0.81) 72.8  (0.81)
Double-blind: Change at Endpoint (n=161,168) 0.5  (1.15) -4.1  (1.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Change at Endpoint (Week 64/LOCF)
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
1.94 to 7.15
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores
Hide Description The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. Number of participants in each specific category; good functioning (PSP total score >70), variable functioning (PSP total score between 31 and 70), and poor functioning (PSP total score <=30) were assessed.
Time Frame Baseline and Endpoint (Week 64/LOCF) in DB period
Hide Outcome Measure Data
Hide Analysis Population Description
DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values.'n' signifies participants who were evaluable at each specified time point for each arm, respectively.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Overall Number of Participants Analyzed 164 170
Measure Type: Number
Unit of Measure: participants
Baseline: Poor (n=164, 170) 0 0
Baseline: Variable (n=164, 170) 69 84
Baseline: Good (n=164, 170) 95 86
Endpoint: Poor (n=161, 168) 1 4
Endpoint: Variable (n=161, 168) 65 95
Endpoint: Good (n=161, 168) 95 69
6.Secondary Outcome
Title Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint
Hide Description 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.
Time Frame Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
Hide Outcome Measure Data
Hide Analysis Population Description
OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Participants did not receive placebo during open-label lead in period and open-label stabilization period.
Overall Number of Participants Analyzed 667 0
Mean (Standard Deviation)
Unit of Measure: Units on a scale
OL Lead-in Period:Baseline (n=667) 85.8  (12.76)
OL Lead-in Period:Change at Endpoint (n=653) -21.8  (16.39)
OL Stabilization Period:Change at Endpoint (n=653) -23.8  (18.30)
7.Secondary Outcome
Title Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint
Hide Description 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.
Time Frame Baseline and Endpoint (Week 64/LOCF) in double-blind period
Hide Outcome Measure Data
Hide Analysis Population Description
DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Overall Number of Participants Analyzed 164 170
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Double-blind: Baseline (n=164, 170) 51.1  (9.50) 51.8  (9.47)
Double-blind: Change at Endpoint (n=161, 168) 0.5  (14.01) 7.4  (18.53)
8.Secondary Outcome
Title Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
Hide Description The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.
Time Frame Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
Hide Outcome Measure Data
Hide Analysis Population Description
OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. n' signifies participants who were evaluable at each specified time point.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Participants did not receive placebo during open-label lead in period and open-label stabilization period.
Overall Number of Participants Analyzed 667 0
Mean (Standard Deviation)
Unit of Measure: Units on a scale
OL Lead-in Period:Baseline (n=667) 20.4  (7.81)
OL Lead-in Period:Change at Endpoint (n=653) -9.7  (8.53)
OL Stabilization Period:Change at Endpoint (n=653) -9.9  (9.08)
9.Secondary Outcome
Title Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
Hide Description The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.
Time Frame Baseline and Endpoint (Week 64/LOCF) in double-blind period
Hide Outcome Measure Data
Hide Analysis Population Description
DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Overall Number of Participants Analyzed 164 170
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Double-blind: Baseline (n=164, 170) 5.7  (3.24) 5.6  (3.32)
Double-blind: Change at Endpoint (n=161, 168) 0.8  (5.40) 3.4  (7.42)
10.Secondary Outcome
Title Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint
Hide Description The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.
Time Frame Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
Hide Outcome Measure Data
Hide Analysis Population Description
OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Participants did not receive placebo during open-label lead in period and open-label stabilization period.
Overall Number of Participants Analyzed 667 0
Mean (Standard Deviation)
Unit of Measure: Units on a scale
OL Lead-in Period:Baseline (n=667) 18.6  (9.48)
OL Lead-in Period:Change at Endpoint (n=653) -9.9  (9.45)
OL Stabilization Period:Change at Endpoint (n=653) -10.5  (10.14)
11.Secondary Outcome
Title Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint
Hide Description The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.
Time Frame Baseline and Endpoint (Week 64/LOCF) in double-blind period
Hide Outcome Measure Data
Hide Analysis Population Description
DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Overall Number of Participants Analyzed 164 170
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Double-blind: Baseline (n=164, 170) 4.4  (3.46) 4.4  (3.40)
Double-blind: Change at Endpoint (n=161,168) -0.1  (5.47) 3.2  (7.21)
12.Secondary Outcome
Title Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint
Hide Description The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit".
Time Frame Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
Hide Outcome Measure Data
Hide Analysis Population Description
OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Participants did not receive placebo during open-label lead in period and open-label stabilization period.
Overall Number of Participants Analyzed 667 0
Mean (Standard Deviation)
Unit of Measure: Units on a scale
OL Lead-in Period:Baseline (n=667) 4.4  (0.58)
OL Lead-in Period:Change at Endpoint (n=652) -1.3  (0.99)
OL Stabilization Period:Change at Endpoint (n=652) -1.3  (1.07)
13.Secondary Outcome
Title Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint
Hide Description The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit".
Time Frame Baseline and Endpoint (Week 64/LOCF) in double-blind period
Hide Outcome Measure Data
Hide Analysis Population Description
DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.
Arm/Group Title Paliperidone Palmitate Placebo
Hide Arm/Group Description:
DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Overall Number of Participants Analyzed 164 170
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Double-blind: Baseline (n=164, 170) 2.4  (0.68) 2.5  (0.69)
Double-blind: Change at Endpoint (n=161,168) 0.0  (1.02) 0.4  (1.15)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label - Paliperidone Palmitate Double Blind - Paliperidone Palmitate Double Blind - Placebo
Hide Arm/Group Description Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period. DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment. Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants during DB relapse prevention period.
All-Cause Mortality
Open Label - Paliperidone Palmitate Double Blind - Paliperidone Palmitate Double Blind - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open Label - Paliperidone Palmitate Double Blind - Paliperidone Palmitate Double Blind - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54/667 (8.10%)   9/164 (5.49%)   16/170 (9.41%) 
Cardiac disorders       
Atrioventricular Block Complete * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Cardiac Failure Congestive * 1  0/667 (0.00%)  1/164 (0.61%)  0/170 (0.00%) 
Cardiogenic Shock * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Congestive Cardiomyopathy * 1  0/667 (0.00%)  1/164 (0.61%)  0/170 (0.00%) 
Coronary Artery Disease * 1  0/667 (0.00%)  1/164 (0.61%)  0/170 (0.00%) 
Myocardial Infarction * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Ear and labyrinth disorders       
Meniere's Disease * 1  0/667 (0.00%)  0/164 (0.00%)  1/170 (0.59%) 
Gastrointestinal disorders       
Colitis * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Gastrooesophageal Reflux Disease * 1  0/667 (0.00%)  1/164 (0.61%)  0/170 (0.00%) 
Vomiting * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
General disorders       
Chest Pain * 1  0/667 (0.00%)  1/164 (0.61%)  0/170 (0.00%) 
Hyperthermia * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Infections and infestations       
Bronchitis * 1  0/667 (0.00%)  1/164 (0.61%)  0/170 (0.00%) 
Diverticulitis * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Lobar Pneumonia * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Injury, poisoning and procedural complications       
Brain Contusion * 1  0/667 (0.00%)  0/164 (0.00%)  1/170 (0.59%) 
Multiple Injuries * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Overdose * 1  0/667 (0.00%)  1/164 (0.61%)  0/170 (0.00%) 
Road Traffic Accident * 1  0/667 (0.00%)  0/164 (0.00%)  1/170 (0.59%) 
Nervous system disorders       
Coma * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Viith Nerve Paralysis * 1  0/667 (0.00%)  0/164 (0.00%)  1/170 (0.59%) 
Psychiatric disorders       
Completed Suicide * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Confusional State * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Delusion * 1  0/667 (0.00%)  0/164 (0.00%)  1/170 (0.59%) 
Depression * 1  1/667 (0.15%)  2/164 (1.22%)  0/170 (0.00%) 
Depression Suicidal * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Depressive Symptom * 1  2/667 (0.30%)  0/164 (0.00%)  0/170 (0.00%) 
Hallucination, Auditory * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Homicidal Ideation * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Mania * 1  3/667 (0.45%)  0/164 (0.00%)  1/170 (0.59%) 
Paranoia * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Psychotic Disorder * 1  4/667 (0.60%)  2/164 (1.22%)  2/170 (1.18%) 
Restlessness * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Schizoaffective Disorder * 1  16/667 (2.40%)  1/164 (0.61%)  7/170 (4.12%) 
Suicidal Ideation * 1  15/667 (2.25%)  0/164 (0.00%)  2/170 (1.18%) 
Suicide Attempt * 1  2/667 (0.30%)  0/164 (0.00%)  0/170 (0.00%) 
Renal and urinary disorders       
Bladder Prolapse * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Surgical and medical procedures       
Therapy Regimen Changed * 1  1/667 (0.15%)  0/164 (0.00%)  0/170 (0.00%) 
Vascular disorders       
Deep Vein Thrombosis * 1  2/667 (0.30%)  0/164 (0.00%)  0/170 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Open Label - Paliperidone Palmitate Double Blind - Paliperidone Palmitate Double Blind - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   332/667 (49.78%)   79/164 (48.17%)   62/170 (36.47%) 
Endocrine disorders       
Hyperprolactinaemia * 1  9/667 (1.35%)  7/164 (4.27%)  2/170 (1.18%) 
Gastrointestinal disorders       
Constipation * 1  14/667 (2.10%)  2/164 (1.22%)  0/170 (0.00%) 
Diarrhoea * 1  20/667 (3.00%)  4/164 (2.44%)  2/170 (1.18%) 
Dry Mouth * 1  15/667 (2.25%)  0/164 (0.00%)  1/170 (0.59%) 
Nausea * 1  17/667 (2.55%)  2/164 (1.22%)  3/170 (1.76%) 
Toothache * 1  8/667 (1.20%)  5/164 (3.05%)  2/170 (1.18%) 
General disorders       
Fatigue * 1  20/667 (3.00%)  3/164 (1.83%)  0/170 (0.00%) 
Injection Site Pain * 1  71/667 (10.64%)  1/164 (0.61%)  2/170 (1.18%) 
Pyrexia * 1  8/667 (1.20%)  6/164 (3.66%)  2/170 (1.18%) 
Infections and infestations       
Nasopharyngitis * 1  9/667 (1.35%)  9/164 (5.49%)  6/170 (3.53%) 
Upper Respiratory Tract Infection * 1  14/667 (2.10%)  7/164 (4.27%)  4/170 (2.35%) 
Urinary Tract Infection * 1  8/667 (1.20%)  5/164 (3.05%)  4/170 (2.35%) 
Investigations       
Blood Prolactin Increased * 1  4/667 (0.60%)  4/164 (2.44%)  2/170 (1.18%) 
Glycosylated Haemoglobin Increased * 1  1/667 (0.15%)  2/164 (1.22%)  4/170 (2.35%) 
Weight Decreased * 1  2/667 (0.30%)  5/164 (3.05%)  2/170 (1.18%) 
Weight Increased * 1  57/667 (8.55%)  14/164 (8.54%)  8/170 (4.71%) 
Metabolism and nutrition disorders       
Increased Appetite * 1  18/667 (2.70%)  0/164 (0.00%)  0/170 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  14/667 (2.10%)  2/164 (1.22%)  3/170 (1.76%) 
Nervous system disorders       
Akathisia * 1  74/667 (11.09%)  5/164 (3.05%)  3/170 (1.76%) 
Dyskinesia * 1  14/667 (2.10%)  1/164 (0.61%)  3/170 (1.76%) 
Headache * 1  36/667 (5.40%)  9/164 (5.49%)  6/170 (3.53%) 
Parkinsonism * 1  43/667 (6.45%)  3/164 (1.83%)  3/170 (1.76%) 
Somnolence * 1  21/667 (3.15%)  2/164 (1.22%)  2/170 (1.18%) 
Tremor * 1  23/667 (3.45%)  2/164 (1.22%)  4/170 (2.35%) 
Psychiatric disorders       
Anxiety * 1  9/667 (1.35%)  3/164 (1.83%)  4/170 (2.35%) 
Insomnia * 1  67/667 (10.04%)  8/164 (4.88%)  12/170 (7.06%) 
Schizoaffective Disorder * 1  6/667 (0.90%)  4/164 (2.44%)  3/170 (1.76%) 
Suicidal Ideation * 1  16/667 (2.40%)  5/164 (3.05%)  2/170 (1.18%) 
Reproductive system and breast disorders       
Amenorrhoea * 1  18/667 (2.70%)  3/164 (1.83%)  2/170 (1.18%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  10/667 (1.50%)  5/164 (3.05%)  2/170 (1.18%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.1
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.
At least 60 days prior to submitting a manuscript the Site shall provide to Sponsor a copy of all such manuscripts and materials,and allow Sponsor 60 days to review and comment on them. If Sponsor requests, the Site shall remove any Confidential Information prior to submitting the materials.The Site agrees that if Study is part of a multi-center study,any publication by the Institution of results of the Study conducted at the Site shall not be made before the first multi-center publication.
Results Point of Contact
Name/Title: Director of Clinical Development
Organization: Janssen Scientific Affairs, LLC, Titusville, NJ
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01193153     History of Changes
Other Study ID Numbers: CR016618
R092670SCA3004 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Submitted: August 30, 2010
First Posted: September 1, 2010
Results First Submitted: December 22, 2014
Results First Posted: January 5, 2015
Last Update Posted: January 5, 2015