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

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215579
• Other study ID #: 5631
• Secondary ID: RIS-SCH-421
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: September 19, 2014
• Start date: April 2004
• Est. completion date: April 2006

Study information

• Verified date: March 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Depot Risperidone Microsphere (Consta)

Locations

Country	Name	City	State
United States	John Umstead Hospital	Butner	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Janssen, LP

Country where clinical trial is conducted

United States,