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

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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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

John Umstead Hospital

Butner, North Carolina, 27509, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Depot Risperidone Microsphere (Consta)

Drug

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

Janssen, LP

Registry information

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Sep 22, 2005
Registry last updated: Sep 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed