Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression
Trial Summary
What is the purpose of this trial?
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.
Research Team
David Bond, MD
Principal Investigator
University of British Columbia
Lakshmi Yatham, MD
Principal Investigator
University of British Columbia
Edwin Tam, MD
Principal Investigator
University of British Columbia
Mauricio Kunz, Dr.
Principal Investigator
University of British Columbia
Kyooseob Ha, Dr.
Principal Investigator
Seoul National University Bundang Hospital
Wetid Pratoomsri, Dr.
Principal Investigator
Chachoengsao Hospital Thailand
Eligibility Criteria
Inclusion Criteria
Treatment Details
Interventions
- Lamotrigine (Anti-epileptic drug)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Dr. Christopher Haqq
University of British Columbia
Chief Medical Officer since 2019
MD, University of British Columbia
Bekki Bracken Brown
University of British Columbia
Chief Executive Officer since 2023
Bachelor's degree from Duke University