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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: January 15, 2013
Last verified: March 2012
History of Changes
  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:

Drug Information available for: Risperidone
U.S. FDA Resources

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
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: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
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 June 18, 2013