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Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01662648
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : March 26, 2014
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone ER
Enrollment 1117
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Hide Arm/Group Description Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy. Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Period Title: Overall Study
Started 520 597
Completed 373 419
Not Completed 147 178
Reason Not Completed
Death             1             3
Adverse Event             40             37
Lack of Efficacy             17             16
Participant ineligible to continue trial             1             1
Lost to Follow-up             24             36
Withdrawal by Subject             36             53
Participant non-compliant             16             20
Other             8             11
Adverse event and lack of efficacy (LOE)             3             0
LOE and other reason unspecified             1             0
LOE and Participant non-compliant             0             1
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other Total
Hide Arm/Group Description Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy. Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons. Total of all reporting groups
Overall Number of Baseline Participants 520 597 1117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 520 participants 597 participants 1117 participants
Less than (<) 25 years 92 125 217
Greater than or equal to (>=) 25 to < 35 years 153 191 344
>= 35 to < 45 years 152 152 304
>= 45 to < 55 years 83 87 170
>= 55 to < 65 years 33 34 67
>= 65 to < 75 years 6 7 13
Greater than 75 years 1 1 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 520 participants 597 participants 1117 participants
Female
192
  36.9%
268
  44.9%
460
  41.2%
Male
328
  63.1%
329
  55.1%
657
  58.8%
1.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26
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. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Overall Number of Participants Analyzed 508 583
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 85.19  (24.97) 65.45  (28.48)
Week 26 -26.60  (28.24) -20.52  (30.05)
2.Secondary Outcome
Title Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26
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. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Overall Number of Participants Analyzed 508 583
Measure Type: Number
Unit of Measure: percentage of participants
72.83 71.87
3.Secondary Outcome
Title Change From Baseline in PANSS Total Positive Subscale Score at Week 26
Hide Description The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Overall Number of Participants Analyzed 508 583
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 21.04  (7.15) 15.26  (7.53)
Week 26 -7.17  (7.67) -5.07  (7.88)
4.Secondary Outcome
Title Change From Baseline in PANSS Total Negative Subscale Score at Week 26
Hide Description The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Overall Number of Participants Analyzed 508 583
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 22.73  (7.86) 16.90  (8.13)
Week 26 -6.93  (7.96) -5.32  (8.12)
5.Secondary Outcome
Title Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26
Hide Description The CGI 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 indicates to "normal, not at all ill" and a rating of 7 indicates "among the most extremely ill participants". Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Overall Number of Participants Analyzed 508 583
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 4.24  (0.83) 3.29  (1.12)
Week 26 -1.12  (1.28) -0.98  (1.30)
6.Secondary Outcome
Title Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26
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. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Overall Number of Participants Analyzed 506 583
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n= 506, 583) 55.07  (15.68) 66.03  (15.65)
Week 26 (n= 501, 574) 13.76  (17.80) 11.14  (17.53)
7.Secondary Outcome
Title Change From Baseline in Sleep Quality at Week 26
Hide Description Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Overall Number of Participants Analyzed 507 581
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
Baseline (n= 507, 581) 63.53  (27.37) 67.40  (27.13)
Week 26 (n= 504, 574) 11.57  (35.70) 8.19  (35.93)
8.Secondary Outcome
Title Change From Baseline in Daytime Drowsiness at Week 26
Hide Description Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: "not at all" to 100:"all the time"). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Overall Number of Participants Analyzed 507 581
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
Baseline (n= 507, 581 ) 32.80  (27.56) 34.54  (28.61)
Week 26 (n= 504, 574) -9.52  (32.29) -11.54  (34.53)
9.Secondary Outcome
Title Number of Participants Within Each Category of Patient Satisfaction Score
Hide Description Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment."N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies those participants who were evaluated for this measure at specified time point.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Hide Arm/Group Description:
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Overall Number of Participants Analyzed 507 583
Measure Type: Number
Unit of Measure: participants
Very Good: Baseline (n= 507, 583) 8 21
Good: Baseline (n= 507, 583) 74 151
Reasonable: Baseline (n= 507, 583) 256 305
Moderate: Baseline (n= 507, 583) 158 97
Poor: Baseline (n= 507, 583) 11 9
Very Good: Week 26 (n=492, 563) 120 156
Good: Week 26 (n=492, 563) 173 253
Reasonable: Week 26 (n=492, 563) 112 94
Moderate: Week 26 (n=492, 563) 70 50
Poor: Week 26 (n=492, 563) 17 10
Time Frame 26 weeks
Adverse Event Reporting Description Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
 
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Hide Arm/Group Description Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy. Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
All-Cause Mortality
Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Affected / at Risk (%) Affected / at Risk (%)
Total   35/512 (6.84%)   29/587 (4.94%) 
Cardiac disorders     
Cardiac arrest * 1  0/512 (0.00%)  1/587 (0.17%) 
Eye disorders     
Oculogyration * 1  1/512 (0.20%)  0/587 (0.00%) 
Gastrointestinal disorders     
Vomiting * 1  1/512 (0.20%)  2/587 (0.34%) 
Nausea * 1  1/512 (0.20%)  1/587 (0.17%) 
Gastritis * 1  0/512 (0.00%)  1/587 (0.17%) 
Gastrointestinal haemorrhage * 1  1/512 (0.20%)  0/587 (0.00%) 
Intestinal obstruction * 1  0/512 (0.00%)  1/587 (0.17%) 
General disorders     
 * 1  0/512 (0.00%)  2/587 (0.34%) 
Infections and infestations     
Paronychia * 1  1/512 (0.20%)  0/587 (0.00%) 
Injury, poisoning and procedural complications     
Poisoning * 1  1/512 (0.20%)  0/587 (0.00%) 
Drowning * 1  1/512 (0.20%)  0/587 (0.00%) 
Investigations     
Investigation * 1  1/512 (0.20%)  2/587 (0.34%) 
Weight decreased * 1  1/512 (0.20%)  0/587 (0.00%) 
Blood pressure increased * 1  1/512 (0.20%)  0/587 (0.00%) 
Metabolism and nutrition disorders     
Anorexia * 1  1/512 (0.20%)  0/587 (0.00%) 
Diabetes mellitus * 1  0/512 (0.00%)  1/587 (0.17%) 
Hypokalaemia * 1  1/512 (0.20%)  0/587 (0.00%) 
Diabetes mellitus inadequate control * 1  0/512 (0.00%)  1/587 (0.17%) 
Nervous system disorders     
Extrapyramidal disorder * 1  0/512 (0.00%)  3/587 (0.51%) 
Cerebrovascular accident * 1  0/512 (0.00%)  1/587 (0.17%) 
Akathisia * 1  0/512 (0.00%)  1/587 (0.17%) 
Dyskinesia * 1  1/512 (0.20%)  0/587 (0.00%) 
Dystonia * 1  1/512 (0.20%)  0/587 (0.00%) 
Poor quality sleep * 1  1/512 (0.20%)  0/587 (0.00%) 
Speech disorder * 1  1/512 (0.20%)  0/587 (0.00%) 
Tremor * 1  1/512 (0.20%)  0/587 (0.00%) 
Convulsion * 1  1/512 (0.20%)  0/587 (0.00%) 
Psychiatric disorders     
Schizophrenia * 1  12/512 (2.34%)  7/587 (1.19%) 
Psychotic disorder * 1  7/512 (1.37%)  3/587 (0.51%) 
Aggression * 1  1/512 (0.20%)  2/587 (0.34%) 
Agitation * 1  2/512 (0.39%)  1/587 (0.17%) 
Hallucination * 1  1/512 (0.20%)  1/587 (0.17%) 
Suicidal behaviour * 1  1/512 (0.20%)  1/587 (0.17%) 
Abnormal behaviour * 1  1/512 (0.20%)  0/587 (0.00%) 
Delusion * 1  1/512 (0.20%)  0/587 (0.00%) 
Delusion of grandeur * 1  0/512 (0.00%)  1/587 (0.17%) 
Grandiosity * 1  1/512 (0.20%)  0/587 (0.00%) 
Hallucination, auditory * 1  0/512 (0.00%)  1/587 (0.17%) 
Hostility * 1  1/512 (0.20%)  0/587 (0.00%) 
Mania * 1  0/512 (0.00%)  1/587 (0.17%) 
Schizoaffective disorder * 1  0/512 (0.00%)  1/587 (0.17%) 
Schizophrenia, disorganized type * 1  0/512 (0.00%)  1/587 (0.17%) 
Acute psychosis * 1  1/512 (0.20%)  0/587 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  0/512 (0.00%)  1/587 (0.17%) 
Tachypnoea * 1  0/512 (0.00%)  1/587 (0.17%) 
Asthma * 1  1/512 (0.20%)  0/587 (0.00%) 
Pneumonia * 1  1/512 (0.20%)  0/587 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash * 1  0/512 (0.00%)  1/587 (0.17%) 
Vascular disorders     
Hypotension * 1  1/512 (0.20%)  0/587 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability, Compliance or Other
Affected / at Risk (%) Affected / at Risk (%)
Total   208/512 (40.63%)   239/587 (40.72%) 
Cardiac disorders     
Palpitations * 1  6/512 (1.17%)  6/587 (1.02%) 
Eye disorders     
Oculogyration * 1  0/512 (0.00%)  6/587 (1.02%) 
Gastrointestinal disorders     
Nausea * 1  17/512 (3.32%)  23/587 (3.92%) 
Vomiting * 1  15/512 (2.93%)  16/587 (2.73%) 
Salivary hypersecretion * 1  0/512 (0.00%)  7/587 (1.19%) 
Constipation * 1  8/512 (1.56%)  8/587 (1.36%) 
General disorders     
Pyrexia * 1  0/512 (0.00%)  9/587 (1.53%) 
Investigations     
Weight increased * 1  0/512 (0.00%)  9/587 (1.53%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal stiffness * 1  0/512 (0.00%)  8/587 (1.36%) 
Nervous system disorders     
Extrapyramidal disorder * 1  34/512 (6.64%)  21/587 (3.58%) 
Headache * 1  23/512 (4.49%)  24/587 (4.09%) 
Dizziness * 1  16/512 (3.13%)  22/587 (3.75%) 
Akathisia * 1  13/512 (2.54%)  18/587 (3.07%) 
Somnolence * 1  9/512 (1.76%)  20/587 (3.41%) 
Tremor * 1  9/512 (1.76%)  12/587 (2.04%) 
Parkinsonism * 1  0/512 (0.00%)  6/587 (1.02%) 
Poor quality sleep * 1  9/512 (1.76%)  0/587 (0.00%) 
Psychiatric disorders     
Insomnia * 1  50/512 (9.77%)  68/587 (11.58%) 
Restlessness * 1  9/512 (1.76%)  13/587 (2.21%) 
Anxiety * 1  0/512 (0.00%)  9/587 (1.53%) 
Psychotic disorder * 1  9/512 (1.76%)  0/587 (0.00%) 
Depression * 1  0/512 (0.00%)  6/587 (1.02%) 
Reproductive system and breast disorders     
Amenorrhoea * 1  0/512 (0.00%)  7/587 (1.19%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/512 (0.00%)  6/587 (1.02%) 
Skin and subcutaneous tissue disorders     
Rash * 1  0/512 (0.00%)  6/587 (1.02%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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: Regional Medical Franchis Director AP
Organization: Janssen China
Phone: +86 10 582 187 66
Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01662648     History of Changes
Other Study ID Numbers: CR013534
R076477SCH3024 ( Other Identifier: Janssen Pharmaceutica )
First Submitted: August 8, 2012
First Posted: August 10, 2012
Results First Submitted: December 17, 2013
Results First Posted: March 26, 2014
Last Update Posted: May 5, 2014