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
|Condition or disease||Intervention/treatment||Phase|
|Schizoaffective Disorder Schizophrenia||Drug: IM risperidone Drug: oral antipsychotic medication||Phase 3|
The purpose of the study is to assess the effectiveness of long-acting injectable risperidone on psychiatric inpatient hospitalization, schizophrenia symptoms, quality of life, medication adherence, side effects, and health care costs.
Primary: To evaluate the impact of long-acting intramuscular (IM) risperidone on risk of inpatient psychiatric hospitalization in comparison to standard oral antipsychotic treatment in a randomized controlled trial to be conducted with 450 veterans diagnosed with schizophrenia or schizoaffective disorder at 16 VA medical centers over three years.
Secondary: To evaluate adherence, health benefits, and costs of long-acting IM risperidone as compared to standard oral antipsychotic treatment as measured by: a) symptom reduction over 12 months, b) time to all-cause medication discontinuation, c) quality of life, d) VA and non-VA health service use and related costs, e) medication side effects, f) violent behavior, g) use of concomitant medication, and h) the incremental cost-effectiveness ratio.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||382 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CSP #555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Experimental: Arm 1
long-acting injectable risperidone
Drug: IM risperidone
long-acting injectable risperidone
Active Comparator: Arm 2
oral antipsychotic medication
Drug: oral antipsychotic medication
doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)
- Hospitalization-free Survival - Time to Event [ Time Frame: From randomization until date of first re-hospitalization, assessed up to 24 months ]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.
- Hazard Ratio for Hospitalization [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132314
Show 19 Study Locations
|Study Chair:||Robert A. Rosenheck, AB MD||VA Connecticut Health Care System (West Haven)|