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A Study of Relapse Prevention and the Effectiveness of Long-acting Injectable Risperidone and Quetiapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

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ClinicalTrials.gov Identifier: NCT00216476
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : August 10, 2010
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Schizophrenia
Psychotic Disorders
Interventions Drug: Aripiprazole
Drug: Risperidone Long Acting Injectable (LAI)
Drug: Quetiapine
Enrollment 753
Recruitment Details Subjects had a diagnosis of schizophrenia or schizoaffective disorder (according to the Diagnostic and Statistical Manual of Mental Disorders - 4th edition [DSM-IV]) and were treated with oral risperidone, olanzapine, or conventional oral neuroleptic monotherapy at screening. They were to be symptomatically stable but not optimally treated.
Pre-assignment Details  
Arm/Group Title Risperidone LAI Quetiapine Aripiprazole
Hide Arm/Group Description Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.) oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
Period Title: Overall Study
Started 329 337 45
Completed 224 230 28
Not Completed 105 107 17
Reason Not Completed
Withdrawal by Subject             59             72             9
Lost to Follow-up             10             9             1
Adverse Event             6             10             1
Lack of Efficacy             4             3             0
Death             2             0             0
Pregnancy             0             1             1
Other             0             0             1
Refuses Injection             11             0             0
No Further Need for Treatment             3             4             1
Non-compliance             0             4             1
Higher dose/Extra Medication Required             2             0             2
Administrative Reasons             1             1             0
Protocol Deviation             5             1             0
Patient Moved             2             2             0
Arm/Group Title Risperidone LAI Quetiapine Total
Hide Arm/Group Description intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks oral, target dose of 300-400 mg b.i.d. or t.i.d. Total of all reporting groups
Overall Number of Baseline Participants 329 337 666
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 329 participants 337 participants 666 participants
40.6  (12.48) 42.6  (13.14) 41.6  (12.85)
[1]
Measure Description: As aripiprazole was not part of the primary analysis but was only added for exploratory purposes, data on this arm are not presented here.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants 337 participants 666 participants
Female
134
  40.7%
146
  43.3%
280
  42.0%
Male
195
  59.3%
191
  56.7%
386
  58.0%
[1]
Measure Description: As aripiprazole was not part of the primary analysis but was only added for exploratory purposes, data on this arm are not presented here.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants 337 participants 666 participants
Caucasian 320 330 650
Oriental 1 2 3
Hispanic 2 0 2
Black 1 0 1
Arab 5 4 9
Pakistani 0 1 1
[1]
Measure Description: As aripiprazole was not part of the primary analysis but was only added for exploratory purposes, data on this arm are not presented here.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 329 participants 337 participants 666 participants
27.6  (5.23) 27.0  (5.32) 27.3  (5.28)
[1]
Measure Description: As aripiprazole was not part of the primary analysis but was only added for exploratory purposes, data on this arm are not presented here.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 329 participants 337 participants 666 participants
80.4  (16.93) 79.0  (17.75) 79.7  (17.35)
[1]
Measure Description: As aripiprazole was not part of the primary analysis but was only added for exploratory purposes, data on this arm are not presented here.
1.Primary Outcome
Title Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)
Hide Description Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method.
Time Frame Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm and 11 of the quetiapine arm.
Arm/Group Title Risperidone LAI Quetiapine
Hide Arm/Group Description:
intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
oral, target dose of 300-400 mg b.i.d. or t.i.d.
Overall Number of Participants Analyzed 327 326
Mean (Standard Deviation)
Unit of Measure: days
607  (11.4) 533  (15.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone LAI, Quetiapine
Comments Null hypothesis was that there is no difference in treatment effect between risperidone LAI and quetiapine by mean relapse free period; given a estimated relapse rate of 30% for risperidone LAI and 42% for quetiapine, with 80% power and 5% 2-tailed significance level, 251 subjects were needed per treatment arm. To adjust for an estimated 20% discontinuations for reasons other than relapse, 628 subjects in total were needed. Actual relapse rates were 17% (risperidone LAI) and 31% (quetiapine).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments threshold for significance: 0.05 (2-sided)
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Mean Relapse Free Period (Exploratory/Aripiprazole)
Hide Description As for risperidone and quetiapine, relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. Since aripiprazole was new on the market at the time the study was conducted, this aripiprazole analysis was exploratory.
Time Frame Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 1 subject of the aripiprazole arm.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
oral, recommended maintenance dose of 10-30 mg q.d.
Overall Number of Participants Analyzed 44
Mean (Standard Error)
Unit of Measure: days
314  (20.4)
3.Secondary Outcome
Title Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score
Hide Description

The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item PANSS scale. The PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, i.e., the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).

Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme).

Time Frame Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. One additional subject in each the risperidone LAI and quetiapine arm did not have PANSS data.
Arm/Group Title Risperidone LAI Quetiapine Aripiprazole
Hide Arm/Group Description:
Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
Overall Number of Participants Analyzed 326 325 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.3  (25.65) -1.1  (26.28) -7.7  (27.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone LAI, Quetiapine
Comments Between-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Risperidone LAI
Comments Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Quetiapine
Comments Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1026
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon signed-rank test
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score
Hide Description The 7-point CGI scale of Severity (CGI-S) was used to assess the severity of a subject’s psychotic condition (0= normal, not at all ill, 1= borderline, etc. and 6= among the most extremely ill subjects).
Time Frame Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Month 24 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm, 11 of the quetipaine arm, and 1 of the aripiprazole arm. One additional subject in the risperidone LAI arm did not have CGI data.
Arm/Group Title Risperidone LAI Quetiapine Aripiprazole
Hide Arm/Group Description:
Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
Overall Number of Participants Analyzed 326 326 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.3  (1.25) 0.1  (1.24) -0.1  (1.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone LAI, Quetiapine
Comments Between-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Risperidone LAI
Comments Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Quetiapine
Comments Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0446
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon signed-rank test
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores
Hide Description Quality of life was assessed by means of the 12-item SF-12® survey. Two parameters, i.e., PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better QOL.
Time Frame Assessed at the moment the subject was randomized to a treatment arm (baseline visit) and after 1, 3, 6, 12, 18, and 24 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. An additional 32, 32, and 2 subjects in the respective arms did not have SF-12 data.
Arm/Group Title Risperidone LAI Quetiapine Aripiprazole
Hide Arm/Group Description:
Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
Overall Number of Participants Analyzed 295 294 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
PCS score 2.1  (9.04) 1.0  (9.31) 2.4  (10.36)
MCS score 3.2  (10.43) 2.7  (10.88) 4.9  (12.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone LAI, Quetiapine
Comments Between-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0941
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Risperidone LAI
Comments Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Quetiapine
Comments Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1146
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Risperidone LAI, Quetiapine
Comments Between-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5589
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Risperidone LAI
Comments Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Quetiapine
Comments Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical test was interpreted at the 5% significance level.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Time Frame All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and 6 weeks after the last injection of risperidone LAI or the last intake of quetiapine or aripiprazole (24 months after baseline) were reported.
Adverse Event Reporting Description AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
 
Arm/Group Title Risperidone LAI Quetiapine Aripiprazole
Hide Arm/Group Description Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.) oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
All-Cause Mortality
Risperidone LAI Quetiapine Aripiprazole
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Risperidone LAI Quetiapine Aripiprazole
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   63/329 (19.15%)   77/337 (22.85%)   7/45 (15.56%) 
Blood and lymphatic system disorders       
Acquired methaemoglobinaemia  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Refractory anemia  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Cardiac disorders       
Acute myocardial infarction  1  0/329 (0.00%)  0/337 (0.00%)  1/45 (2.22%) 
Myocardial infarction  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Endocrine disorders       
Hypothyroidism  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Gastrointestinal disorders       
Abdominal pain upper  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Constipation  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Gastic ulcer  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Inguinal hernia  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Peptic ulcer perforation  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
General disorders       
Asthenia  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Condition aggravated  1  1/329 (0.30%)  2/337 (0.59%)  0/45 (0.00%) 
Infections and infestations       
Anal abscess  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Anal fistula  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Bronchitis  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Pneumonia  1  2/329 (0.61%)  1/337 (0.30%)  0/45 (0.00%) 
Injury, poisoning and procedural complications       
Alcohol poisoning  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Ankle fracture  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Brain contusion  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Drug toxicity  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Fall  1  1/329 (0.30%)  1/337 (0.30%)  0/45 (0.00%) 
Head injury  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Joint dislocation  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Lung injury  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Multiple fractures  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Poisoning  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Tibia fracture  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Wrist fracture  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Investigations       
Drug level decreased  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  1/329 (0.30%)  1/337 (0.30%)  0/45 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cyst  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Ovarian cancer  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Uterine leiomyoma  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Nervous system disorders       
Akathisia  1  1/329 (0.30%)  1/337 (0.30%)  0/45 (0.00%) 
Cerebrovascular accident  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Coma  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Dizziness  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Epilepsy  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Headache  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Ischaemic stroke  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Parkinsonism  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Status epilepticus  1  0/329 (0.00%)  0/337 (0.00%)  1/45 (2.22%) 
Psychiatric disorders       
Abnormal behavior  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Acute psychosis  1  1/329 (0.30%)  2/337 (0.59%)  0/45 (0.00%) 
Affect lability  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Aggression  1  3/329 (0.91%)  1/337 (0.30%)  0/45 (0.00%) 
Agitation  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Alcoholism  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Anxiety  1  1/329 (0.30%)  5/337 (1.48%)  0/45 (0.00%) 
Completed suicide  1  2/329 (0.61%)  1/337 (0.30%)  0/45 (0.00%) 
Delirium  1  1/329 (0.30%)  0/337 (0.00%)  1/45 (2.22%) 
Delusion  1  1/329 (0.30%)  4/337 (1.19%)  1/45 (2.22%) 
Depression  1  2/329 (0.61%)  3/337 (0.89%)  0/45 (0.00%) 
Depression suicidal  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Disturbance in social behavior  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Hallucination  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Insomnia  1  2/329 (0.61%)  3/337 (0.89%)  0/45 (0.00%) 
Irritability  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Major depression  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Mental disorder  1  2/329 (0.61%)  1/337 (0.30%)  0/45 (0.00%) 
Panic disorder  1  2/329 (0.61%)  0/337 (0.00%)  0/45 (0.00%) 
Psychotic disorder  1  8/329 (2.43%)  14/337 (4.15%)  2/45 (4.44%) 
Restlessness  1  0/329 (0.00%)  2/337 (0.59%)  0/45 (0.00%) 
Schizoaffective disorder  1  1/329 (0.30%)  7/337 (2.08%)  0/45 (0.00%) 
Schizophrenia  1  14/329 (4.26%)  23/337 (6.82%)  0/45 (0.00%) 
Schizophrenia, disorganized type  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Schizophrenia, paranoid type  1  4/329 (1.22%)  4/337 (1.19%)  0/45 (0.00%) 
Self injurious behavior  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Sleep disorder  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Suicidal ideation  1  5/329 (1.52%)  1/337 (0.30%)  0/45 (0.00%) 
Suicide attempt  1  5/329 (1.52%)  2/337 (0.59%)  0/45 (0.00%) 
Suspiciousness  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Renal and urinary disorders       
Renal failure acute  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Reproductive system and breast disorders       
Ovarian cyst  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/329 (0.00%)  0/337 (0.00%)  1/45 (2.22%) 
Chronic obstructive airways disease  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Respiratory failure  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Skin and subcutaneous tissue disorders       
Urticaria  1  0/329 (0.00%)  1/337 (0.30%)  0/45 (0.00%) 
Social circumstances       
Family stress  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Social problem  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Surgical and medical procedures       
Cyst removal  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Surgery  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  1/329 (0.30%)  0/337 (0.00%)  0/45 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Risperidone LAI Quetiapine Aripiprazole
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   201/329 (61.09%)   213/337 (63.20%)   28/45 (62.22%) 
Endocrine disorders       
Hyperprolactinaemia  1  43/329 (13.07%)  5/337 (1.48%)  0/45 (0.00%) 
Gastrointestinal disorders       
Nausea  1  1/329 (0.30%)  6/337 (1.78%)  5/45 (11.11%) 
General disorders       
Asthenia  1  2/329 (0.61%)  11/337 (3.26%)  3/45 (6.67%) 
Investigations       
Weight decreased  1  1/329 (0.30%)  6/337 (1.78%)  3/45 (6.67%) 
Weight increased  1  23/329 (6.99%)  20/337 (5.93%)  2/45 (4.44%) 
Nervous system disorders       
Dizziness  1  2/329 (0.61%)  15/337 (4.45%)  4/45 (8.89%) 
Headache  1  19/329 (5.78%)  16/337 (4.75%)  5/45 (11.11%) 
Somnolence  1  6/329 (1.82%)  38/337 (11.28%)  0/45 (0.00%) 
Psychiatric disorders       
Anxiety  1  39/329 (11.85%)  30/337 (8.90%)  7/45 (15.56%) 
Delusion  1  4/329 (1.22%)  4/337 (1.19%)  4/45 (8.89%) 
Depression  1  15/329 (4.56%)  16/337 (4.75%)  3/45 (6.67%) 
Insomnia  1  36/329 (10.94%)  31/337 (9.20%)  11/45 (24.44%) 
Schizophrenia  1  4/329 (1.22%)  17/337 (5.04%)  0/45 (0.00%) 
Sleep disorder  1  8/329 (2.43%)  2/337 (0.59%)  3/45 (6.67%) 
Tension  1  14/329 (4.26%)  14/337 (4.15%)  3/45 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
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: EMEA Medical Affairs Director Psychiatry
Organization: Janssen Cilag European Medical Affairs
Phone: +34 91 7228043
Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT00216476     History of Changes
Other Study ID Numbers: CR002269
First Submitted: September 13, 2005
First Posted: September 22, 2005
Results First Submitted: July 8, 2010
Results First Posted: August 10, 2010
Last Update Posted: April 16, 2014