Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00215579
First received: September 14, 2005
Last updated: September 19, 2014
Last verified: March 2012
  Purpose

As many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis. This may lead to worsening of symptoms. Clinicians commonly respond to these problems by adding adjunctive medications, despite the absence of systematic studies that support such practices. It is possible, however, that in many of these cases, the unstable course and/or unsatisfactory treatment response reflects incomplete adherence with the originally prescribed oral antipsychotic, rather than a need for adjunctive medications. This study will examine whether switching patients who demonstrate an unstable course and/or an unsatisfactory clinical response to a long-acting injectable preparation as the primary antipsychotic may enhance medication adherence and improve outcomes.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Depot Risperidone Microsphere (Consta)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Duke University:

Enrollment: 64
Study Start Date: April 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients will be male or female
  • Between 18-65 years of age and will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
  • The subject must have, in their physicians opinion, an unstable course and must have been treated with an oral antipsychotic.

Exclusion Criteria:

  • Pregnant and breast feeding females will be excluded.
  • Because fluoxetine is known to change the plasma level of CONSTA, subjects taking fluoxetine within two weeks of starting the study will be excluded.
  • Patients who are known to have a hypersensitivity to oral Risperdal will be excluded.
  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: NCT00215579

Locations
United States, North Carolina
John Umstead Hospital
Butner, North Carolina, United States, 27509
Sponsors and Collaborators
Duke University
Janssen, LP
Investigators
Principal Investigator: William H Wilson, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00215579     History of Changes
Other Study ID Numbers: 5631, RIS-SCH-421
Study First Received: September 14, 2005
Last Updated: September 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Psychotic Disorders
Schizophrenia
Mental Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 22, 2014