Grant: Randomized Controlled Trials

People with bipolar I disorder (BDI) expereince episodes of both mania and depression. Manic episodes are characterized by unusually elevated mood, increased energy, and impulsivity, to the point that people often behave recklessly or dangerously. During depressions, in contrast, people feel unrelentingly sad, fatigued, and hopeless, and may even experience suicidal thoughts. Commonly used medications for BDI, such as mood stabilizers, are ineffective in preventing depressive episodes in large numbers of people. As a result, antidepressant medications are prescribed to up to 70% of people with BDI, and half of those people continue to take the antidepressant medications for 1 year or longer. While antidepressants in combination with mood stabilizers have been shown to treat acute depressive episodes, and to not be associated with with an increased risk of mania during short-term treatment, no well-desgned research studies have been carried out to determine if they help to prevent depression when taken during long-term treatment, or whether they might increase the frequency of manic episodes. We will carry out a randomized controlled trial to answer these questions. People with BDI who recently recovered from a depressive episode while taking a mood stabilizer and an antidepressant will keep taking their mood stabilizer, and will either continue the antidepressant for 1 year, or will replace it with a placebo (sugar pill) after 2 months. Neither the patients nor the researchers will know if the person is receiving the antidepressant or the placebo. People in the study will be followed regualrly to make sure thay are not relapsing into depression or mania. By carrying out this study, we will determine if antidepressant medications are safe and effective in preventing mood episodes during long-term treatment. If so, they will help to keep people with BDI well, and prevent the disability and frequent need for hospitaliation that is associated with depression.