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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. We 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. We hypothesize that people who take Lamotrigine plus and 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 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
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 | nwalji@exchange.ubc.ca |
| Canada, British Columbia | |
| University of British Columbia Mood Disorders Centre | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Nazlin Walji 604 822-7294 nwalji@exchange.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: | University of British Columbia ( Dr. David Bond ) |
| Study ID Numbers: | H06-03732 |
| Study First Received: | May 15, 2007 |
| Last Updated: | September 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00475137 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Bipolar II Disorder depression Lamotrigine Add On antidepressant |
randomized single blind parallel group |
|
Depression Molecular Mechanisms of Pharmacological Action Psychotropic Drugs Calcium Channel Blockers Cardiovascular Agents Depressive Disorder Pharmacologic Actions Behavioral Symptoms |
Membrane Transport Modulators Mental Disorders Therapeutic Uses Mood Disorders Lamotrigine Central Nervous System Agents Anticonvulsants Antidepressive Agents |