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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261430
• Other study ID #: CR002893
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2005
• Last updated: May 16, 2011
• Est. completion date: October 2004

Study information

• Verified date: April 2010
• Source: Janssen, LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• GAIN Acceptance Approach

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen, LP

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Schizophrenia Treatment Acceptance Response Trial