Risperidone LA Heathcare Resource Study

November 27, 2017 updated by: Ric Procyshyn, University of British Columbia

Risperidone Long Acting: A Healthcare Resource Utilization Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Screening (Week -2 to Week 0; Days -14 to -1) In this phase, the subject is required to be treated with oral risperidone (as their only antipsychotic) for a period of at least 5 days before entering the stabilization phase of the study. Therefore,

  • 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.

Stabilization Phase (Weeks 1 - 14; Days 0 - 98) The first three doses of risperidone long acting (Days 0, 14 and 28) will be 25 mg for all subjects. At the time of the fourth injection (Day 42), the dosage of risperidone long acting may be increased from 25 mg IM to 37.5 mg IM upon discretion of the treating physician. Further increases in the dosage of risperidone long acting may be made at the time of the 6th and 8th injections (Days 70 and 98 respectively). In this case, if the subject is currently receiving 25 mg he/she may be increased to 37.5 mg but not 50 mg. Alternatively, if the patient is currently receiving 37.5 mg, then subject may be increased to the maximum recommended dosage of 50 mg IM every two weeks.

To accommodate for the latency period (i.e., the time for risperidone to be released from the microspheres and approach therapeutic plasma levels), subjects entering into the study will continue on oral risperidone for the first three weeks (Days 0-21). Temporary oral supplementation will also be permitted anytime during the stabilization phase of the study when considered by the treating physician to be clinically necessary for the treatment of breakthrough psychosis. With only one exception, the treating physician is not restricted from adding or discontinuing any pharmacological treatment deemed necessary for the clinical management of the subject. The exception in this case prohibits the addition of another antipsychotic agent and applies only to the stabilization phase of the study.

Maintenance Phase (Weeks 15 - 38; Days 99 - 266) Patients that have shown adequate response to risperidone long acting will continue into the maintenance phase of the study. From this point onwards, the treating physician may change the dosage of risperidone long acting at any time as considered necessary. Temporary oral supplementation will also be permitted during the maintenance phase when considered by the treating physician to be clinically necessary for the treatment of breakthrough psychosis. Apart from the above, the treating physician is not restricted from adding or discontinuing any pharmacological treatment (including another antipsychotic) deemed necessary for the clinical management of the subject.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada
        • Riverview Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Risperidone LAI

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
See Detailed Description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Relapse
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

Secondary Outcome Measures

Outcome Measure
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
To evaluate the safety and tolerability of risperidone long acting. This will be evaluated by assessing:
Extrapyramidal symptoms (ESRS)
Side effects (UKU side effect rating scale)
Akathisia (Barnes akathisia scale)
Quality of life (SF-36)
Weight, and waist circumference
Hematology (fasting glucose and lipid analysis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Riverview Hospital

Investigators

  • Principal Investigator: Ric Procyshyn, MD, The University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 3, 2006

First Submitted That Met QC Criteria

January 3, 2006

First Posted (Estimate)

January 6, 2006

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C05-0356

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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