Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01157351
Recruitment Status : Completed
First Posted : July 7, 2010
Results First Posted : December 4, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Schizophrenia
Interventions Drug: paliperidone
Drug: risperidone
Drug: haloperidole
Drug: perphenazine
Drug: aripiprazole
Drug: quetiapine
Drug: paliperidone palmitate
Drug: olanzapine
Enrollment 450
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone Palmitate Oral Antipsychotics
Hide Arm/Group Description Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months. One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
Period Title: Overall Study
Started 230 220
Treated 226 218
Completed 93 88
Not Completed 137 132
Reason Not Completed
Adverse Event             5             4
Death             1             0
Lost to Follow-up             53             55
Withdrawal by Subject             37             27
Physician Decision             5             4
Protocol Violation             0             1
Other             32             36
Noncompliance with Study Drug             0             3
Randomized but not Treated             4             2
Arm/Group Title Paliperidone Palmitate Oral Antipsychotics Total
Hide Arm/Group Description Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months. One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months. Total of all reporting groups
Overall Number of Baseline Participants 226 218 444
Hide Baseline Analysis Population Description
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 226 participants 218 participants 444 participants
37.7  (10.57) 38.6  (10.36) 38.1  (10.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 218 participants 444 participants
Female
33
  14.6%
28
  12.8%
61
  13.7%
Male
193
  85.4%
190
  87.2%
383
  86.3%
Baseline Personal and Social Performance (PSP) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 226 participants 218 participants 444 participants
54.8  (12.83) 55.0  (12.73) 54.9  (12.76)
[1]
Measure Description: The PSP score assesses degree of difficulty within 4 domains of behavior using 6-point Likert scale(0=absent to 5=very severe).The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores=better functioning.
Baseline Clinical Global Impression - Severity (CGI-S) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 226 participants 218 participants 444 participants
3.8  (0.80) 3.9  (0.70) 3.8  (0.75)
[1]
Measure Description: The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.
1.Primary Outcome
Title Time to First Treatment Failure
Hide Description Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.
Time Frame From date of randomization up to Month 15
Hide Outcome Measure Data
Hide Analysis Population Description
Explanatory Intent-to-Treat (eITT) population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.
Arm/Group Title Paliperidone Palmitate Oral Antipsychotics
Hide Arm/Group Description:
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
Overall Number of Participants Analyzed 226 218
Median (95% Confidence Interval)
Unit of Measure: Days
416 [1] 
(285 to NA)
226
(147 to 304)
[1]
Upper limit of 95 percent (%) confidence interval was not estimable due to insufficient number of participants with event.
2.Primary Outcome
Title Percentage of Participants in Each Event Category of First Treatment Failure
Hide Description First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.
Time Frame From date of randomization up to Month 15
Hide Outcome Measure Data
Hide Analysis Population Description
eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.
Arm/Group Title Paliperidone Palmitate Oral Antipsychotics
Hide Arm/Group Description:
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
Overall Number of Participants Analyzed 226 218
Measure Type: Number
Unit of Measure: percentage of participants
Treatment Failure Due to Any Event 39.8 53.7
Arrest/incarceration 21.2 29.4
Psychiatric hospitalization 8.0 11.9
D/C due to safety/tolerability 6.6 3.7
Treatment supplementation 2.2 2.8
D/C due to inadequate efficacy 0.4 4.1
Increase in level of psychiatric services 1.3 1.8
Suicide 0 0
3.Secondary Outcome
Title Time to First Psychiatric Hospitalization or Arrest/Incarceration
Hide Description A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant’s clinically significant worsening of symptoms of schizophrenia.
Time Frame From date of randomization up to Month 15
Hide Outcome Measure Data
Hide Analysis Population Description
eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.
Arm/Group Title Paliperidone Palmitate Oral Antipsychotics
Hide Arm/Group Description:
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
Overall Number of Participants Analyzed 226 218
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
274
(202 to 407)
[1]
Median and 95% confidence interval was not estimable due to insufficient number of participants with event.
4.Secondary Outcome
Title Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration
Hide Description The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants’ degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score <=30 represents poor function that requires intensive supervision.
Time Frame Baseline up to Month 15
Hide Outcome Measure Data
Hide Analysis Population Description
eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Paliperidone Palmitate Oral Antipsychotics
Hide Arm/Group Description:
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
Overall Number of Participants Analyzed 203 185
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
5.75  (0.690) 5.36  (0.690)
5.Secondary Outcome
Title Time to First Psychiatric Hospitalization
Hide Description A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the “Assessment of Treatment Failure – Psychiatric Hospitalization.”
Time Frame From date of randomization up to Month 15
Hide Outcome Measure Data
Hide Analysis Population Description
eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.
Arm/Group Title Paliperidone Palmitate Oral Antipsychotics
Hide Arm/Group Description:
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
Overall Number of Participants Analyzed 226 218
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and 95% confidence interval was not estimable due to insufficient number of participants with event.
6.Secondary Outcome
Title Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration
Hide Description The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.
Time Frame Baseline up to Month 15
Hide Outcome Measure Data
Hide Analysis Population Description
eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Paliperidone Palmitate Oral Antipsychotics
Hide Arm/Group Description:
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
Overall Number of Participants Analyzed 219 205
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.48  (0.038) -0.43  (0.037)
Time Frame [Not Specified]
Adverse Event Reporting Description Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
 
Arm/Group Title Paliperidone Palmitate Oral Antipsychotics
Hide Arm/Group Description Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months. One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
All-Cause Mortality
Paliperidone Palmitate Oral Antipsychotics
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone Palmitate Oral Antipsychotics
Affected / at Risk (%) Affected / at Risk (%)
Total   42/226 (18.58%)   53/218 (24.31%) 
Cardiac disorders     
Cardiac Failure Congestive * 1  0/226 (0.00%)  1/218 (0.46%) 
Coronary Artery Disease * 1  0/226 (0.00%)  1/218 (0.46%) 
Gastrointestinal disorders     
Haematemesis * 1  1/226 (0.44%)  0/218 (0.00%) 
Intestinal Obstruction * 1  1/226 (0.44%)  0/218 (0.00%) 
Vomiting * 1  1/226 (0.44%)  0/218 (0.00%) 
General disorders     
Asthenia * 1  0/226 (0.00%)  1/218 (0.46%) 
Chest Pain * 1  0/226 (0.00%)  1/218 (0.46%) 
Drug Withdrawal Syndrome * 1  0/226 (0.00%)  1/218 (0.46%) 
Non-cardiac Chest Pain * 1  1/226 (0.44%)  0/218 (0.00%) 
Sudden Death * 1  1/226 (0.44%)  0/218 (0.00%) 
Immune system disorders     
Hypersensitivity * 1  0/226 (0.00%)  1/218 (0.46%) 
Infections and infestations     
Acquired Immunodeficiency Syndrome * 1  1/226 (0.44%)  0/218 (0.00%) 
Cellulitis * 1  2/226 (0.88%)  1/218 (0.46%) 
Cholecystitis Infective * 1  0/226 (0.00%)  1/218 (0.46%) 
H1N1 Influenza * 1  1/226 (0.44%)  0/218 (0.00%) 
HIV Infection * 1  1/226 (0.44%)  0/218 (0.00%) 
Otitis Media * 1  0/226 (0.00%)  1/218 (0.46%) 
Pneumonia * 1  1/226 (0.44%)  1/218 (0.46%) 
Sepsis * 1  1/226 (0.44%)  0/218 (0.00%) 
Wound Infection * 1  0/226 (0.00%)  1/218 (0.46%) 
Injury, poisoning and procedural complications     
Accidental Overdose * 1  1/226 (0.44%)  0/218 (0.00%) 
Alcohol Poisoning * 1  1/226 (0.44%)  0/218 (0.00%) 
Gun Shot Wound * 1  0/226 (0.00%)  1/218 (0.46%) 
Hip Fracture * 1  0/226 (0.00%)  1/218 (0.46%) 
Intentional Overdose * 1  1/226 (0.44%)  1/218 (0.46%) 
Lower Limb Fracture * 1  0/226 (0.00%)  1/218 (0.46%) 
Overdose * 1  1/226 (0.44%)  0/218 (0.00%) 
Perirenal Haematoma * 1  1/226 (0.44%)  0/218 (0.00%) 
Traumatic Brain Injury * 1  1/226 (0.44%)  0/218 (0.00%) 
Traumatic Lung Injury * 1  1/226 (0.44%)  0/218 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  0/226 (0.00%)  1/218 (0.46%) 
Hyponatraemia * 1  1/226 (0.44%)  0/218 (0.00%) 
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis * 1  1/226 (0.44%)  0/218 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric Cancer Stage III * 1  1/226 (0.44%)  0/218 (0.00%) 
Nervous system disorders     
Akathisia * 1  1/226 (0.44%)  0/218 (0.00%) 
Cerebellar Ataxia * 1  1/226 (0.44%)  0/218 (0.00%) 
Convulsion * 1  0/226 (0.00%)  1/218 (0.46%) 
Dystonia * 1  0/226 (0.00%)  1/218 (0.46%) 
Encephalitis * 1  1/226 (0.44%)  0/218 (0.00%) 
Epilepsy * 1  0/226 (0.00%)  1/218 (0.46%) 
Facial Paresis * 1  0/226 (0.00%)  1/218 (0.46%) 
Ischaemic Stroke * 1  0/226 (0.00%)  1/218 (0.46%) 
Presyncope * 1  0/226 (0.00%)  1/218 (0.46%) 
Syncope * 1  0/226 (0.00%)  1/218 (0.46%) 
Pregnancy, puerperium and perinatal conditions     
Stillbirth * 1  0/226 (0.00%)  1/218 (0.46%) 
Psychiatric disorders     
Acute Psychosis * 1  1/226 (0.44%)  2/218 (0.92%) 
Aggression * 1  0/226 (0.00%)  1/218 (0.46%) 
Agitation * 1  2/226 (0.88%)  0/218 (0.00%) 
Alcohol Withdrawal Syndrome * 1  2/226 (0.88%)  1/218 (0.46%) 
Alcoholism * 1  2/226 (0.88%)  0/218 (0.00%) 
Delusion * 1  1/226 (0.44%)  0/218 (0.00%) 
Depression * 1  4/226 (1.77%)  1/218 (0.46%) 
Depression Suicidal * 1  1/226 (0.44%)  0/218 (0.00%) 
Depressive Symptom * 1  1/226 (0.44%)  0/218 (0.00%) 
Factitious Disorder * 1  0/226 (0.00%)  1/218 (0.46%) 
Hallucination * 1  0/226 (0.00%)  1/218 (0.46%) 
Hallucination, Auditory * 1  1/226 (0.44%)  1/218 (0.46%) 
Hallucinations, Mixed * 1  1/226 (0.44%)  0/218 (0.00%) 
Homicidal Ideation * 1  0/226 (0.00%)  3/218 (1.38%) 
Mania * 1  1/226 (0.44%)  0/218 (0.00%) 
Mental Status Changes * 1  1/226 (0.44%)  0/218 (0.00%) 
Paranoia * 1  2/226 (0.88%)  0/218 (0.00%) 
Polysubstance Dependence * 1  0/226 (0.00%)  1/218 (0.46%) 
Psychotic Behaviour * 1  0/226 (0.00%)  1/218 (0.46%) 
Psychotic Disorder * 1  11/226 (4.87%)  7/218 (3.21%) 
Schizoaffective Disorder Bipolar Type * 1  0/226 (0.00%)  1/218 (0.46%) 
Schizophrenia * 1  4/226 (1.77%)  11/218 (5.05%) 
Schizophrenia, Paranoid Type * 1  4/226 (1.77%)  5/218 (2.29%) 
Substance Abuse * 1  1/226 (0.44%)  0/218 (0.00%) 
Suicidal Ideation * 1  5/226 (2.21%)  11/218 (5.05%) 
Suicide Attempt * 1  1/226 (0.44%)  3/218 (1.38%) 
Renal and urinary disorders     
Renal Failure Acute * 1  1/226 (0.44%)  2/218 (0.92%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome * 1  1/226 (0.44%)  0/218 (0.00%) 
Asthma * 1  1/226 (0.44%)  1/218 (0.46%) 
Pneumothorax * 1  1/226 (0.44%)  0/218 (0.00%) 
Pulmonary Embolism * 1  1/226 (0.44%)  0/218 (0.00%) 
Status Asthmaticus * 1  0/226 (0.00%)  1/218 (0.46%) 
Vascular disorders     
Deep Vein Thrombosis * 1  1/226 (0.44%)  0/218 (0.00%) 
Hypertension * 1  0/226 (0.00%)  1/218 (0.46%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Paliperidone Palmitate Oral Antipsychotics
Affected / at Risk (%) Affected / at Risk (%)
Total   178/226 (78.76%)   155/218 (71.10%) 
Endocrine disorders     
Hyperprolactinaemia * 1  7/226 (3.10%)  4/218 (1.83%) 
Gastrointestinal disorders     
Abdominal Discomfort * 1  0/226 (0.00%)  5/218 (2.29%) 
Constipation * 1  7/226 (3.10%)  8/218 (3.67%) 
Diarrhoea * 1  4/226 (1.77%)  7/218 (3.21%) 
Dry Mouth * 1  15/226 (6.64%)  18/218 (8.26%) 
Dyspepsia * 1  7/226 (3.10%)  3/218 (1.38%) 
Nausea * 1  9/226 (3.98%)  6/218 (2.75%) 
Salivary Hypersecretion * 1  7/226 (3.10%)  0/218 (0.00%) 
Toothache * 1  11/226 (4.87%)  13/218 (5.96%) 
Vomiting * 1  2/226 (0.88%)  5/218 (2.29%) 
General disorders     
Fatigue * 1  17/226 (7.52%)  6/218 (2.75%) 
Injection Site Pain * 1  42/226 (18.58%)  0/218 (0.00%) 
Irritability * 1  4/226 (1.77%)  6/218 (2.75%) 
Pain * 1  1/226 (0.44%)  5/218 (2.29%) 
Infections and infestations     
Bronchitis * 1  6/226 (2.65%)  5/218 (2.29%) 
Influenza * 1  4/226 (1.77%)  5/218 (2.29%) 
Nasopharyngitis * 1  15/226 (6.64%)  14/218 (6.42%) 
Upper Respiratory Tract Infection * 1  13/226 (5.75%)  11/218 (5.05%) 
Injury, poisoning and procedural complications     
Joint Sprain * 1  2/226 (0.88%)  6/218 (2.75%) 
Laceration * 1  4/226 (1.77%)  12/218 (5.50%) 
Investigations     
Blood Prolactin Increased * 1  11/226 (4.87%)  2/218 (0.92%) 
Semen Volume Decreased * 1  5/226 (2.21%)  0/218 (0.00%) 
Weight Increased * 1  30/226 (13.27%)  16/218 (7.34%) 
Metabolism and nutrition disorders     
Abnormal Weight Gain * 1  11/226 (4.87%)  4/218 (1.83%) 
Increased Appetite * 1  16/226 (7.08%)  8/218 (3.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  7/226 (3.10%)  3/218 (1.38%) 
Back Pain * 1  13/226 (5.75%)  8/218 (3.67%) 
Musculoskeletal Stiffness * 1  5/226 (2.21%)  1/218 (0.46%) 
Pain in Extremity * 1  9/226 (3.98%)  8/218 (3.67%) 
Nervous system disorders     
Akathisia * 1  26/226 (11.50%)  17/218 (7.80%) 
Dizziness * 1  6/226 (2.65%)  11/218 (5.05%) 
Dyskinesia * 1  6/226 (2.65%)  4/218 (1.83%) 
Dystonia * 1  5/226 (2.21%)  5/218 (2.29%) 
Extrapyramidal Disorder * 1  5/226 (2.21%)  4/218 (1.83%) 
Headache * 1  17/226 (7.52%)  19/218 (8.72%) 
Sedation * 1  15/226 (6.64%)  18/218 (8.26%) 
Somnolence * 1  10/226 (4.42%)  16/218 (7.34%) 
Tremor * 1  5/226 (2.21%)  3/218 (1.38%) 
Psychiatric disorders     
Agitation * 1  5/226 (2.21%)  5/218 (2.29%) 
Anxiety * 1  25/226 (11.06%)  18/218 (8.26%) 
Depression * 1  19/226 (8.41%)  17/218 (7.80%) 
Hallucination, Auditory * 1  3/226 (1.33%)  6/218 (2.75%) 
Insomnia * 1  42/226 (18.58%)  27/218 (12.39%) 
Libido Decreased * 1  13/226 (5.75%)  3/218 (1.38%) 
Schizophrenia * 1  7/226 (3.10%)  6/218 (2.75%) 
Suicidal Ideation * 1  4/226 (1.77%)  9/218 (4.13%) 
Reproductive system and breast disorders     
Amenorrhoea * 1  5/226 (2.21%)  1/218 (0.46%) 
Erectile Dysfunction * 1  17/226 (7.52%)  1/218 (0.46%) 
Galactorrhoea * 1  5/226 (2.21%)  0/218 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  7/226 (3.10%)  6/218 (2.75%) 
Nasal Congestion * 1  6/226 (2.65%)  1/218 (0.46%) 
Oropharyngeal Pain * 1  5/226 (2.21%)  0/218 (0.00%) 
Vascular disorders     
Hypertension * 1  2/226 (0.88%)  8/218 (3.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
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.
Results Point of Contact
Name/Title: Director, Clinical Development
Organization: Janssen Research & Development
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01157351     History of Changes
Other Study ID Numbers: CR015625
R092670SCH3006 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Submitted: May 3, 2010
First Posted: July 7, 2010
Results First Submitted: November 28, 2014
Results First Posted: December 4, 2014
Last Update Posted: April 24, 2015