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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00261430
Enrollment
650
Registered
2005-12-05
Start date
Unknown
Completion date
2004-10-31
Last updated
2011-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, acceptance, motivational enhancement therapy, long-acting risperidone, intramuscular injection, Treatment Guidebook, GAIN Acceptance Approach

Brief 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.

Detailed 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.

Interventions

BEHAVIORALGAIN Acceptance Approach

Sponsors

Janssen, LP
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026