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Long-Acting Injectable Risperidone in the Treatment of Schizophrenia

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ClinicalTrials.gov Identifier: NCT00132314
Recruitment Status : Completed
First Posted : August 19, 2005
Results First Posted : December 20, 2013
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Schizoaffective Disorder
Schizophrenia
Interventions Drug: IM risperidone
Drug: oral antipsychotic medication
Enrollment 382
Recruitment Details September 2006 - December 2008; 19 VA medical centers
Pre-assignment Details  
Arm/Group Title Injectable Risperidone Oral Antipsychotic
Hide Arm/Group Description long-acting injectable risperidone oral antipsychotic medication
Period Title: Overall Study
Started 190 192
Received Treatment 188 185
Completed Baseline Visit, Provided SSN 187 [1] 182 [2]
Completed 117 120
Not Completed 73 72
Reason Not Completed
Lost to Follow-up             70             62
Lacked SSN             1             3
Refused intervention at baseline             2             7
[1]
This is the ITT cohort
[2]
This is the ITT cohort.
Arm/Group Title Injectable Risperidone Oral Antipsychotic Total
Hide Arm/Group Description long-acting injectable risperidone oral antipsychotic medication Total of all reporting groups
Overall Number of Baseline Participants 187 182 369
Hide Baseline Analysis Population Description
We used the intention to treat (ITT) population as defined in Milestone 2.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 187 participants 182 participants 369 participants
50.6  (9.7) 51.3  (8.8) 50.9  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 182 participants 369 participants
Female
15
   8.0%
17
   9.3%
32
   8.7%
Male
172
  92.0%
165
  90.7%
337
  91.3%
1.Primary Outcome
Title Hospitalization-free Survival - Time to Event
Hide Description A hospitalization-free survival was defined as the time from the date of randomization to the time of a psychiatric hospitalization (in both VA and non-VA hospitals) or, in the case of patients who were hospitalized at randomization, the time from the date of discharge from the initial stay to subsequent hospitalization. Patients without an event were censored at 24 months after the date of randomization.
Time Frame From randomization until date of first re-hospitalization, assessed up to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Injectable Risperidone Oral Antipsychotic
Hide Arm/Group Description:
long-acting injectable risperidone
oral antipsychotic medication
Overall Number of Participants Analyzed 187 182
Median (95% Confidence Interval)
Unit of Measure: years
NA [1] 
(1.84 to NA)
1.97 [2] 
(1.19 to NA)
[1]
The median time to event based on Kaplan-Meier estimates was not reached, and upper 95% confidence interval could not be estimated
[2]
Upper 95% confidence interval could not be estimated
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Injectable Risperidone, Oral Antipsychotic
Comments Time-to-event analysis; The primary outcome hypothesis is tested using a two-sided log-rank test to compare the hazard rate for the IM treatment group to that for the oral treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.63 to 1.20
Estimation Comments [Not Specified]
2.Primary Outcome
Title Hazard Ratio for Hospitalization
Hide Description Hazard ratio of LAI versus Oral for psychiatric hospitalization (in both VA and non-VA hospitals), after randomization up to 24 months, obtained from a Cox proportional hazards model.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Injectable Risperidone Oral Antipsychotic
Hide Arm/Group Description:
long-acting injectable risperidone
oral antipsychotic medication
Overall Number of Participants Analyzed 187 182
Measure Type: Number
Unit of Measure: participants
Patients with psychiatric hospitalization 72 81
Patients without psychiatric hospitalization 115 101
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Injectable Risperidone, Oral Antipsychotic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments 95% Confidence Interval: 0.63 to 1.20
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.63 to 1.20
Estimation Comments [Not Specified]
Time Frame Adverse events were collected from enrollment to 30 days after the end of follow-up. Subjects were followed for up to 36 months, depending on when the participant was enrolled in the study.
Adverse Event Reporting Description Participants were monitored for adverse events (AEs) and serious adverse events (SAEs) at monthly study visits. AEs and SAEs were both actively and passively monitored.
 
Arm/Group Title Injectable Risperidone Oral Antipsychotic
Hide Arm/Group Description long-acting injectable risperidone oral antipsychotic medication
All-Cause Mortality
Injectable Risperidone Oral Antipsychotic
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Injectable Risperidone Oral Antipsychotic
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   96/187 (51.34%)      91/182 (50.00%)    
Cardiac disorders     
Atrial fibrillation  1  0/187 (0.00%)  0 1/182 (0.55%)  4
Atrial flutter  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Bradycardia  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Duodenal stenosis  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Gastrooesophageal reflux disease  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Irritable bowel syndrome  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Pancreatitis  1  0/187 (0.00%)  0 1/182 (0.55%)  1
General disorders     
Chest pain  1  4/187 (2.14%)  5 0/182 (0.00%)  0
Death  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Drowning  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Ulcer haemorrhage  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Infections and infestations     
Bronchitis  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Cellulitis  1  1/187 (0.53%)  1 1/182 (0.55%)  1
Diverticulitis  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Empyema  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Gastroenteritis  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Pneumonia  1  5/187 (2.67%)  5 1/182 (0.55%)  1
Postoperative wound infection  1  2/187 (1.07%)  2 0/182 (0.00%)  0
Urinary tract infection  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Injury, poisoning and procedural complications     
Accidental overdose  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Alcohol poisoning  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Drug toxicity  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Fall  1  1/187 (0.53%)  1 2/182 (1.10%)  2
Heat stroke  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Joint dislocation  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Post procedural complication  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Road traffic accident  1  2/187 (1.07%)  2 0/182 (0.00%)  0
Investigations     
Anticonvulsant drug level increased  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Antipsychotic drug level above therapeutic  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Weight increased  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Diabetes mellitus non-insulin-dependent  1  1/187 (0.53%)  1 1/182 (0.55%)  1
Hyperglycaemia  1  2/187 (1.07%)  2 1/182 (0.55%)  1
Hypoglycaemic unconsciousness  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Hypokalaemia  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Spinal osteoarthritis  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Lung neoplasm  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Multiple myeloma  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Prostate cancer  1  0/187 (0.00%)  0 2/182 (1.10%)  2
Nervous system disorders     
Sedation  1  1/187 (0.53%)  1 1/182 (0.55%)  1
Syncope  1  2/187 (1.07%)  2 1/182 (0.55%)  1
Tardive dyskinesia  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Vascular dementia  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Psychiatric disorders     
Completed suicide  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Depression  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Homicidal ideation  1  7/187 (3.74%)  7 8/182 (4.40%)  10
Mental status changes  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Schizophrenia  1  47/187 (25.13%)  87 56/182 (30.77%)  104
Suicidal behaviour  1  1/187 (0.53%)  1 1/182 (0.55%)  1
Suicidal ideation  1  37/187 (19.79%)  51 38/182 (20.88%)  63
Suicide attempt  1  4/187 (2.14%)  4 9/182 (4.95%)  9
Renal and urinary disorders     
Renal failure acute  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  2/187 (1.07%)  3 1/182 (0.55%)  1
Dyspnoea  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Hypoxia  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Pulmonary congestion  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Respiratory failure  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Social circumstances     
Drug abuser  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Substance abuse  1  1/187 (0.53%)  1 1/182 (0.55%)  1
Surgical and medical procedures     
Drug detoxification  1  2/187 (1.07%)  2 0/182 (0.00%)  0
Hospitalisation  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Knee arthroplasty  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Pleural decortication  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Radical prostatectomy  1  1/187 (0.53%)  1 0/182 (0.00%)  0
Vascular disorders     
Vascular pseudoaneurysm  1  0/187 (0.00%)  0 1/182 (0.55%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Injectable Risperidone Oral Antipsychotic
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   132/187 (70.59%)      123/182 (67.58%)    
Ear and labyrinth disorders     
Vertigo  1  21/187 (11.23%)  26 22/182 (12.09%)  28
Eye disorders     
Vision blurred  1  10/187 (5.35%)  10 12/182 (6.59%)  14
Gastrointestinal disorders     
Constipation  1  22/187 (11.76%)  33 20/182 (10.99%)  25
Diarrhoea  1  14/187 (7.49%)  15 13/182 (7.14%)  15
Dry mouth  1  21/187 (11.23%)  34 22/182 (12.09%)  29
Salivary hypersecretion  1  13/187 (6.95%)  16 7/182 (3.85%)  10
Vomiting  1  26/187 (13.90%)  34 24/182 (13.19%)  34
General disorders     
Chest pain  1  10/187 (5.35%)  15 9/182 (4.95%)  10
Fatigue  1  24/187 (12.83%)  29 23/182 (12.64%)  32
Infections and infestations     
Nasopharyngitis  1  13/187 (6.95%)  19 11/182 (6.04%)  13
Investigations     
Weight increased  1  14/187 (7.49%)  15 6/182 (3.30%)  6
Musculoskeletal and connective tissue disorders     
Arthralgia  1  8/187 (4.28%)  10 10/182 (5.49%)  10
Back pain  1  7/187 (3.74%)  8 13/182 (7.14%)  15
Pain in extremity  1  11/187 (5.88%)  13 5/182 (2.75%)  5
Nervous system disorders     
Akathisia  1  22/187 (11.76%)  28 12/182 (6.59%)  13
Extrapyramidal disorder  1  14/187 (7.49%)  21 9/182 (4.95%)  9
Headache  1  32/187 (17.11%)  44 25/182 (13.74%)  35
Sedation  1  13/187 (6.95%)  14 16/182 (8.79%)  17
Psychiatric disorders     
Insomnia  1  35/187 (18.72%)  52 44/182 (24.18%)  60
Renal and urinary disorders     
Dysuria  1  10/187 (5.35%)  13 13/182 (7.14%)  14
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/187 (4.28%)  8 12/182 (6.59%)  12
Skin and subcutaneous tissue disorders     
Rash  1  18/187 (9.63%)  26 13/182 (7.14%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Robert Rosenheck, MD
Organization: VA New England Mental Illness, Research, Education and Clinical Center
Phone: (203) 932-5711 ext 3723
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00132314     History of Changes
Other Study ID Numbers: 555
First Submitted: August 17, 2005
First Posted: August 19, 2005
Results First Submitted: May 29, 2013
Results First Posted: December 20, 2013
Last Update Posted: December 20, 2013