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

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ClinicalTrials.gov Identifier: NCT00215579
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2014
Information provided by (Responsible Party):

September 14, 2005
September 22, 2005
September 22, 2014
April 2004
April 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00215579 on ClinicalTrials.gov Archive Site
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Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence
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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.
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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
Drug: Depot Risperidone Microsphere (Consta)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2006
April 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
RIS-SCH-421 ( Other Identifier: Study specific ID )
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Duke University
Duke University
Janssen, LP
Principal Investigator: William H Wilson, PhD Duke University
Duke University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP