Bipolar II Depression: Lithium, SSRI, or the Combination

Bipolar type II depression (BD II) is a less severe type of bipolar disorder. BD II is
characterized by one or more depressive episodes and at least one hypomanic episode. During
hypomanic episodes, people experience especially energetic or anxious moods, and their
thoughts are more sporadic than usual, but they do not experience the severity of mania.
Symptoms of BD II are known to impair daily functioning as well as cause distress and even
suicide. Antidepressant medication alone is not recommended for people with bipolar disorder
because manic symptoms usually worsen. It is unknown whether the same recommendation should
apply to people with BD II. Sertraline is a selective serotonin reuptake inhibitor (SSRI)
antidepressant that increases levels of serotonin, helping the brain to maintain mental
stability. It is often used to treat depression, panic attacks, and other disorders. Lithium
is a mood stabilizing medication that decreases abnormal brain activity and is used to treat
and prevent recurring episodes of mania in people with bipolar disorders. This study will
evaluate the effectiveness of lithium alone, sertraline alone, and lithium with sertraline
to treat symptoms of BD II.

Participation in this double-blind study will last up to 18 weeks. Participants will be
randomly assigned to receive either lithium, sertraline, or lithium and sertraline. Both
medications will initially be given at a low dose and then gradually increased over 2 weeks.
For the remainder of the study, dosages will be adjusted as necessary. Study visits will
occur every week for the first 6 weeks and then every other week for the remaining 10 weeks.
During all study visits, participants will complete a psychiatric assessment and
questionnaires about their current mood and any treatment side effects. Urine and blood
collection may occur at selected times during the study.