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

NCT ID: NCT00215579

Last Updated: 2014-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2006-04-30

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Depot Risperidone Microsphere (Consta)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen, LP

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William H Wilson, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

John Umstead Hospital

Butner, North Carolina, United States

Countries

United States

Other Identifiers

RIS-SCH-421

Identifier Type: OTHER

Identifier Source: secondary_id

5631

Identifier Type: -

Identifier Source: org_study_id