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| Sponsor: | University of British Columbia |
|---|---|
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00475137 |
Purpose
Depression is a medical condition characterized by feeling sad even when good things happen, having low energy and motivation, and sometimes even experiencing suicidal thoughts. Bipolar II Disorder is an illness in which periods of depression alternate with periods of abnormally elevated mood, energy and activity, referred to as hypomania. After Major Depressive Disorder, Bipolar II Disorder is the most common cause of depression. Unfortunately, antidepressant medications, used alone, do not work as well in treating Bipolar depression as they do in treating other kinds of depression. Lamotrigine is a medication which studies show is effective in treating Bipolar depression. The investigators will determine if lamotrigine works best to treat Bipolar II depression if it is used alone, or if it is taken with an antidepressant. In the first part of our investigation, people with Bipolar II depression who have not responded to an antidepressant will either add lamotrigine to their antidepressant, or will stop the antidepressant and take lamotrigine alone. They will see the study doctor for 6 visits over 8 weeks, and will answer questions about their depressive symptoms and their overall health. The purpose of this study phase is to determine which treatment works best to treat active Bipolar depression. In the second part of the study, people who have responded to their assigned treatment may continue to receive it for another 44 weeks. They will see the study doctor monthly, and will answer similar questions about their health. Participants will also receive a physical examination and get a blood test three times during the study. The purpose of the second phase is to ascertain which treatment is best at preventing relapses of depression. The investigators hypothesize that people who take Lamotrigine plus an antidepressant will recover from their depression more completely, have a longer period of wellness, and have better quality of life compared to those taking Lamotrigine alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar II Depression |
Drug: Lamotrigine plus plus antidepressant medication subjects were prescribed prior to study entry Drug: Lamotrigine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Randomized, Single-Blind Comparison of Lamotrigine Add-on Versus Switch to Lamotrigine Monotherapy in the Treatment of Bipolar II Depression Unresponsive to Antidepressant Treatment |
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1.
Subjects will be randomized to one of two study arms at baseline. Those in the first treatment arm will be prescribed lamotrigine in addition to the antidepressant medication they were prescribed prior to study entry.
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Drug: Lamotrigine plus plus antidepressant medication subjects were prescribed prior to study entry
Lamotrigine will be initiated at 25mg daily for two weeks, then increased to 50mg daily for one week, and then increased to 100 mg daily. The dose may then be adjusted upward or downward by 50-100mg weekly, at the investigator's discretion, provided that it remains within the protocol defined range of 100mg - 400mg daily. For subjects in this combination therapy arm, antidepressant dose will remain constant throughout the study.
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Active Comparator: 2.
Subjects in the second treatment arm will discontinue their antidepressants and will be prescribed lamotrigine monotherapy. Lamotrigine will be initiated at 25mg daily for two weeks, then increased to 50mg daily for one week, and then increased to 100 mg daily. The dose may then be adjusted upward or downward by 50-100mg weekly, at the investigator's discretion, provided that it remains within the protocol defined range of 100mg - 400mg daily.
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Drug: Lamotrigine
Lamotrigine will be initiated at 25mg daily for two weeks, then increased to 50mg daily for one week, and then increased to 100 mg daily. The dose may then be adjusted upward or downward by 50-100mg weekly, at the investigator's discretion, provided that it remains within the protocol defined range of 100mg - 400mg daily. Subjects in this group will discontinue their antidepressants prescribed to them before the study.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 17 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects who meet all of the following criteria are eligible to participate in this trial:
Exclusion Criteria:
Subjects meeting any of the following criteria are not eligible to participate in the trial:
Contacts and Locations| Contact: Nazlin Walji | 604-822-7294 | nazlin.walji@ubc.ca |
| Canada, British Columbia | |
| University of British Columbia Mood Disorders Centre | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Nazlin Walji 604 822-7294 nazlin.walji@ubc.ca | |
| Principal Investigator: | David Bond, MD | University of British Columbia |
| Study Director: | Lakshmi Yatham, MD | University of British Columbia |
| Study Director: | Edwin Tam, MD | University of British Columbia |
| Study Director: | Mauricio Kunz, Dr. | University of British Columbia |
| Study Director: | Kyooseob Ha, Dr. | Seoul National University Bundang Hospital |
| Study Director: | Wetid Pratoomsri, Dr. | Chachoengsao Hospital Thailand |
More Information
| Responsible Party: | Dr. David Bond, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00475137 History of Changes |
| Other Study ID Numbers: | H06-03732 |
| Study First Received: | May 15, 2007 |
| Last Updated: | August 10, 2011 |
| Health Authority: | Canada: Health Canada |
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Bipolar II Disorder depression Lamotrigine Add On antidepressant |
randomized single blind parallel group |
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Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Antidepressive Agents Lamotrigine Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anticonvulsants |