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

This study has been completed.
Sponsor:
Information provided by:
Janssen, LP
ClinicalTrials.gov Identifier:
NCT00261430
First received: December 2, 2005
Last updated: May 16, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Behavioral: GAIN Acceptance Approach
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Janssen, LP:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 650
Study Completion Date: October 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261430

Sponsors and Collaborators
Janssen, LP
Investigators
Study Director: Janssen, LP Clinical Trial Janssen, LP
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00261430     History of Changes
Other Study ID Numbers: CR002893
Study First Received: December 2, 2005
Last Updated: May 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen, LP:
Schizophrenia
acceptance
motivational enhancement therapy
long-acting risperidone
intramuscular injection
Treatment Guidebook
GAIN Acceptance Approach

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 27, 2014