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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Depot Risperidone Microsphere (Consta)
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • John Umstead Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
September 19, 2014
Sponsor
Duke University
Collaborators
Janssen, LP
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1. Study Identification

Unique Protocol Identification Number
NCT00215579
Brief Title
Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Janssen, LP

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Depot Risperidone Microsphere (Consta)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William H Wilson, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Umstead Hospital
City
Butner
State/Province
North Carolina
ZIP/Postal Code
27509
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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