Risperidone LA Heathcare Resource Study

NCT00272597 | Completed Phase 4

• 1 other identifier: C05-0356
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosis; Schizophrenia

Keywords

Psychosis; schizophrenia; schizoaffective; risperidone

Outcome Measures

Primary Outcomes (5)

• To assess the impact of switching subjects from an existing antipsychotic to risperidone long acting on healthcare resource utilization. This will be evaluated by assessing:

• Direct cost of care

• Frequency and duration of institutional care

• Discharge

• Relapse

Secondary Outcomes (12)

• To determine if effectiveness is maintained for subjects switched from an existing antipsychotic to risperidone long acting. This will be evaluated by assessing:

• Positive and negative symptoms (PANSS)

• Overall illness severity (CGI severity, CGI improvement)

• Social and occupational functioning (SOFAS), and

• Remission

Study Arms (1)

Risperidone LAI

OTHER

Subjects treated with any antipsychotic can be switched to Risperidone LAI. * If the subject is currently treated with an antipsychotic other than risperidone, the dosage will be tapered gradually and discontinued. Simultaneously, oral risperidone will be started at 2 mg/day and increased to no more than 6 mg/day. The subject will be treated with risperidone monotherapy for at least five days prior to entering the stabilization phase of the study. * On the other hand, if the patient has already been treated for more than 5 days with risperidone monotherapy then he/she may enter the stabilization phase of the study immediately.

Drug: Risperidone

Interventions

Risperidone DRUG

See Detailed Description.

Risperidone LAI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Riverview Hospital: collaborator

Study Sites (1)

Riverview Hospital

Coquitlam, British Columbia, Canada

Location

Related Publications (1)

• Procyshyn RM, Barr AM, Flynn S, Schenk C, Ganesan S, Honer WG. Long-acting injectable risperidone in treatment refractory patients: a 14-week open-label pilot study. Schizophr Res. 2010 Nov;123(2-3):273-5. doi: 10.1016/j.schres.2010.07.016. Epub 2010 Aug 4. No abstract available.

  PMID: 20688481 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ric Procyshyn, MD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 3, 2006
• First Posted: January 6, 2006
• Study Start: September 1, 2005
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

CA (1)