- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00246246
A Randomized, Open-label Trial of Long-acting Injectable Risperidone Versus Oral Antipsychotic Medication in Patients With Bipolar Disorder
February 10, 2011 updated by: Janssen-Ortho Inc., Canada
A Randomized, Open-label Trial of RISPERDAL® CONSTA™ Versus Oral Antipsychotic Care in Subjects With Bipolar Disorder
The purpose of this study is to determine the safety and effectiveness of a long-acting injectable formulation of risperidone in stable bipolar patients randomly switched from their current add-on oral antipsychotic (olanzapine, risperidone, or quetiapine) therapy to long-acting injectable risperidone.
The patients switched to long-acting injectable risperidone will be compared to patients who continue on their oral antipsychotic treatment regimen
Study Overview
Detailed Description
This an open-label, randomized study.
Approximately 40 stable bipolar patients who are on an atypical antipsychotic (olanzapine, risperidone, quetiapine) plus adjunct bipolar treatment consisting of (a maximum or two of lithium, valproate or lamotrigine, and, if applicable, one antidepressant) will be randomized to two arms.
In one arm, 25 milligrams of long-acting injectable risperidone will replace the oral atypical antipsychotic as adjunct therapy and in the other arm, patients will continue with their current atypical antipsychotic therapy.
Trial duration is 6 months.
In the long-acting injectable risperidone arm, the oral atypical antipsychotic will be continued (as supplementation) for 3 weeks after the first injection of long-acting risperidone and then discontinued.
Investigators, based upon the patient's response, may increase the dose of injectable risperidone to 37.5 mg after 6 weeks on the 25-mg dose and to 50 mg after at least 4 weeks on the 37.5-mg dose.
Risperidone oral supplementation is allowed.
In the oral antipsychotic only arm, the oral atypical antipsychotic dose can also be increased as required.
The primary efficacy outcome will be measured by changes in the Clinical Global Impression - Severity of Illness subscale (CGI-S), from baseline to endpoint, and will be compared between the treatment groups.
Safety will be monitored throughout the study.
The primary hypothesis is that patients switched to long-acting injectable risperidone will be able to tolerate this formulation of risperidone and maintain or even improve their reduction in bipolar symptomatology compared with baseline, and compared with subjects who continue in the oral antipsychotic arm.
The secondary hypothesis is that patients switched to long-acting injectable risperidone will have a longer time to intervention for a mood episode (either mania or depression) as compared with subjects who continue in the oral antipsychotic arm.
Risperidone, formulated for intramuscular injection, 25 mg every 2 weeks.
Patients treated with injectable risperidone continue their original oral atypical antipsychotic (AAP) dose for 3 weeks.
Investigators, at their discretion, may increase the dose of injectable risperidone to 37.5 mg after 6 weeks on the 25-mg dose and to 50 mg after at least 4 weeks on the 37.5-mg dose.
Study duration is 6 months.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 3
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stable outpatients meeting the DSM-IV criteria for Bipolar I or Bipolar II Disorder
- YMRS score of <= 19, MADRS score <= 19 and the Clinical Global Impression - Severity of Illness subscale (CGI-S) score <= 4 at screening and baseline
- Must be receiving stable doses of one oral atypical antipsychotic (olanzapine, risperidone, or quetiapine) in combination with a maximum of two of lithium, valproate or lamotrigine, and, if applicable, one antidepressant)
- Subject is healthy on the basis of a pre-trial physical examination, medical history and the results of blood biochemistry, hematology tests or urinalysis tests within 2 weeks of randomization (i.e. during screening)
- Female subjects must be postmenopausal (for at least 1 year), surgically sterile, or practicing an effective method of birth control before entry and throughout the study, and have a negative urine pregnancy test at screening and baseline
Exclusion Criteria:
- Have a serious unstable medical illness
- Had previous treatment with a long-acting injectable antipsychotic medication
- Known to be a risperidone non-responder or have a confirmed or suspected history of hypersensitivity or allergy to risperidone
- Patients at imminent risk of injury to self or others, or of causing significant damage to property
- Current drug or alcohol dependence
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Changes in the Clinical Global Impression - Severity of Illness subscale (CGI-S) from baseline to endpoint, compared between treatment groups
|
Secondary Outcome Measures
Outcome Measure |
---|
Changes from baseline in the YMRS, MADRS and HAM-A at Months 1 - 6 and endpoint; resource utilization (emergency room visits, hospitalizations); quality of life; patient satisfaction with treatment; time to intervention for manic and depressive episodes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2004
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
October 28, 2005
First Submitted That Met QC Criteria
October 28, 2005
First Posted (Estimate)
October 30, 2005
Study Record Updates
Last Update Posted (Estimate)
February 11, 2011
Last Update Submitted That Met QC Criteria
February 10, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Bipolar and Related Disorders
- Disease
- Bipolar Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- CR005818
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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