A 2-year Study of Patients With Schizophrenia Who Are Treated With Long-acting Injectable Risperidone.

Study Overview
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Brief Summary
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The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.

Detailed Description
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Controlled clinical trials for treating schizophrenia often involve selected patients with common characteristics. It is recognized that schizophrenia are much more diverse than those in the clinical setting, and that physician's prescribing practices may vary. The objective of the study is to examine treatment practices for adult schizophrenic patients by their own physicians, and to assess patient outcomes when treated with long-acting risperidone injection. This is a 2-year, prospective, multi-center, longitudinal, observational study in adults with schizophrenia. Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injections and meeting all the study criteria may enroll in the study. Patients will continue their treatment according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (e.g., emergency room visits, hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study. A dose of 25, 37.5 or 50 mg of risperidone, administered every 2 weeks by intramuscular injection.

Official Title
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Schizophrenia Treatment Acceptance Response Trial: a 20-week, Open-label, Multicenter, Randomized Study Comparing the Effect of the GAIN Acceptance Approach Verses the Approach-as-usual in Supporting Patient Acceptance of Long-acting Risperidone (Risperdal� CONSTA�) in Adults With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: GAIN Acceptance Approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia long-term use of antipsychotic medication and taking any oral antipsychotic for 4 weeks before the study stable with respect to disease symptoms and other medical conditions if female, using birth control. Exclusion Criteria: At risk to self or others use of injectable antipsychotics within the past 6 months, of clozapine, or of investigational drugs within 30 days considered to be resistant to treatment pregnant or breast-feeding not using birth control.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: GAIN Acceptance Approach|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| After 12 weeks of treatment, the percentage of patients accepting long-acting risperidone injection switched using the Gain Acceptance Approach compared with those switched using the approach as usual |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Change (CGI-C) to measure disease severity; Patient Attitude/Satisfaction scale and Clinician Attitude/Satisfaction scale after 12 weeks of treatment, measuring satisfaction |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, acceptance, motivational enhancement therapy, long-acting risperidone, intramuscular injection, Treatment Guidebook, GAIN Acceptance Approach