Risperidone LA Heathcare Resource Study

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this pilot study is to evaluate the impact of switching 30 subjects from an existing antipsychotic to risperidone long acting on healthcare resource utilization. The study will be a ten month open-label, 'mirror-image', pilot study. Healthcare resource utilization during the 10 months prior to starting risperidone long acting will be retrospectively collected for all subjects (period A) at the beginning of the study. The utilization of direct medical resources will also be collected for 10 months after initiation of risperidone long acting (period B). In this design the patients will serve as their own control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Riverview Hospital
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Subjects with a diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria.

• Men and women, aged 18-65 years.

• Subjects must be able to give written informed consent.

• Subjects must be inpatients.

• Subjects must have adequate data to assess healthcare resource utilization for the previous 10 months.

• Subjects must have been previously treated with (and tolerated) oral risperidone.

• Results of standard clinical laboratory tests are to be within the laboratory's reference range or, if outside this range, judged by the investigator to be not clinically significant.

Exclusion Criteria:

Exclusion Criteria:

• Subjects with significant alcohol or substance abuse in the past 3 months.

• Subjects with other psychiatric, medical or behavioural comorbid disorder that in the opinion of the investigator may interfere with study conduct or interpretation (such as delirium, stroke, developmental disability).

• Subjects who are pregnant, breast-feeding, or women of child-bearing potential not using adequate contraception.

• Subjects with known hypersensitivity or allergy to risperidone.

• Subjects with tardive dyskinesia or a history of neuroleptic malignant syndrome.

• Subjects with a known history of being unresponsive to risperidone.

• Subjects with a clinically significant electrocardiogram abnormality.