Trial Outcomes & Findings for Long-Acting Injectable Risperidone in the Treatment of Schizophrenia (NCT NCT00132314)

Last Updated: 2013-12-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

382 participants

Primary outcome timeframe

From randomization until date of first re-hospitalization, assessed up to 24 months

Results posted on

2013-12-20

Participant Flow

September 2006 - December 2008; 19 VA medical centers

Participant milestones

Participant milestones
Measure	Injectable Risperidone long-acting injectable risperidone	Oral Antipsychotic oral antipsychotic medication
Overall Study STARTED	190	192
Overall Study Received Treatment	188	185
Overall Study Completed Baseline Visit, Provided SSN	187	182
Overall Study COMPLETED	117	120
Overall Study NOT COMPLETED	73	72

Reasons for withdrawal

Reasons for withdrawal
Measure	Injectable Risperidone long-acting injectable risperidone	Oral Antipsychotic oral antipsychotic medication
Overall Study Lost to Follow-up	70	62
Overall Study Lacked SSN	1	3
Overall Study Refused intervention at baseline	2	7

Baseline Characteristics

Long-Acting Injectable Risperidone in the Treatment of Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Injectable Risperidone n=187 Participants long-acting injectable risperidone	Oral Antipsychotic n=182 Participants oral antipsychotic medication	Total n=369 Participants Total of all reporting groups
Age Continuous	50.6 years STANDARD_DEVIATION 9.7 • n=5 Participants	51.3 years STANDARD_DEVIATION 8.8 • n=7 Participants	50.9 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	172 Participants n=5 Participants	165 Participants n=7 Participants	337 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization until date of first re-hospitalization, assessed up to 24 months

Outcome measures

Outcome measures
Measure	Injectable Risperidone n=187 Participants long-acting injectable risperidone	Oral Antipsychotic n=182 Participants oral antipsychotic medication
Hospitalization-free Survival - Time to Event	NA years Interval 1.84 to The median time to event based on Kaplan-Meier estimates was not reached, and upper 95% confidence interval could not be estimated	1.97 years Interval 1.19 to Upper 95% confidence interval could not be estimated

PRIMARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure	Injectable Risperidone n=187 Participants long-acting injectable risperidone	Oral Antipsychotic n=182 Participants oral antipsychotic medication
Hazard Ratio for Hospitalization Patients with psychiatric hospitalization	72 participants	81 participants
Hazard Ratio for Hospitalization Patients without psychiatric hospitalization	115 participants	101 participants

Adverse Events

Injectable Risperidone

Serious events: 96 serious events

Other events: 132 other events

Deaths: 0 deaths

Oral Antipsychotic

Serious events: 91 serious events

Other events: 123 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Robert Rosenheck, MD

VA New England Mental Illness, Research, Education and Clinical Center

Phone: (203) 932-5711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Injectable Risperidone n=187 participants at risk long-acting injectable risperidone	Oral Antipsychotic n=182 participants at risk oral antipsychotic medication
Ear and labyrinth disorders Vertigo	11.2% 21/187 • Number of events 26 • 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. 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.	12.1% 22/182 • Number of events 28 • 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. 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.
Eye disorders Vision blurred	5.3% 10/187 • Number of events 10 • 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. 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.	6.6% 12/182 • Number of events 14 • 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. 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.
Gastrointestinal disorders Constipation	11.8% 22/187 • Number of events 33 • 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. 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.	11.0% 20/182 • Number of events 25 • 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. 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.
Gastrointestinal disorders Diarrhoea	7.5% 14/187 • Number of events 15 • 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. 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.	7.1% 13/182 • Number of events 15 • 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. 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.
Gastrointestinal disorders Dry mouth	11.2% 21/187 • Number of events 34 • 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. 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.	12.1% 22/182 • Number of events 29 • 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. 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.
Gastrointestinal disorders Salivary hypersecretion	7.0% 13/187 • Number of events 16 • 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. 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.	3.8% 7/182 • Number of events 10 • 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. 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.
Gastrointestinal disorders Vomiting	13.9% 26/187 • Number of events 34 • 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. 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.	13.2% 24/182 • Number of events 34 • 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. 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.
General disorders Chest pain	5.3% 10/187 • Number of events 15 • 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. 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.	4.9% 9/182 • Number of events 10 • 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. 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.
General disorders Fatigue	12.8% 24/187 • Number of events 29 • 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. 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.	12.6% 23/182 • Number of events 32 • 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. 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.
Infections and infestations Nasopharyngitis	7.0% 13/187 • Number of events 19 • 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. 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.	6.0% 11/182 • Number of events 13 • 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. 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.
Investigations Weight increased	7.5% 14/187 • Number of events 15 • 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. 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.	3.3% 6/182 • Number of events 6 • 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. 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.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 8/187 • Number of events 10 • 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. 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.	5.5% 10/182 • Number of events 10 • 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. 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.
Musculoskeletal and connective tissue disorders Back pain	3.7% 7/187 • Number of events 8 • 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. 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.	7.1% 13/182 • Number of events 15 • 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. 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.
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 11/187 • Number of events 13 • 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. 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.	2.7% 5/182 • Number of events 5 • 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. 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.
Nervous system disorders Akathisia	11.8% 22/187 • Number of events 28 • 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. 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.	6.6% 12/182 • Number of events 13 • 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. 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.
Nervous system disorders Extrapyramidal disorder	7.5% 14/187 • Number of events 21 • 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. 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.	4.9% 9/182 • Number of events 9 • 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. 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.
Nervous system disorders Headache	17.1% 32/187 • Number of events 44 • 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. 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.	13.7% 25/182 • Number of events 35 • 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. 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.
Nervous system disorders Sedation	7.0% 13/187 • Number of events 14 • 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. 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.	8.8% 16/182 • Number of events 17 • 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. 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.
Psychiatric disorders Insomnia	18.7% 35/187 • Number of events 52 • 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. 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.	24.2% 44/182 • Number of events 60 • 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. 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.
Renal and urinary disorders Dysuria	5.3% 10/187 • Number of events 13 • 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. 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.	7.1% 13/182 • Number of events 14 • 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. 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.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 8/187 • Number of events 8 • 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. 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.	6.6% 12/182 • Number of events 12 • 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. 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.
Skin and subcutaneous tissue disorders Rash	9.6% 18/187 • Number of events 26 • 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. 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.	7.1% 13/182 • Number of events 15 • 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. 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.