NCT00261430

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for phase_4 schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
Last Updated

May 17, 2011

Status Verified

April 1, 2010

First QC Date

December 2, 2005

Last Update Submit

May 16, 2011

Conditions

Schizophrenia

Keywords

Schizophreniaacceptancemotivational enhancement therapylong-acting risperidoneintramuscular injectionTreatment GuidebookGAIN Acceptance Approach

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

GAIN Acceptance ApproachBEHAVIORAL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Janssen, LP Clinical Trial

    Janssen, LP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 5, 2005

Study Completion

October 1, 2004

Last Updated

May 17, 2011

Record last verified: 2010-04