Schizoaffective Disorder, Schizophrenia
Conditions
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.
Interventions
DRUGDepot Risperidone Microsphere (Consta)
Sponsors
Janssen, LP
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed