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Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Duke University
Janssen, LP
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00215579
  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 IV

MedlinePlus related topics: Psychotic Disorders Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Further study details as provided by Duke University:

Estimated Enrollment: 60
Study Start Date: April 2004
  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

Study ID Numbers: RIS-SCH-421
Study First Received: September 14, 2005
Last Updated: February 7, 2007
ClinicalTrials.gov Identifier: NCT00215579  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009