This study will compare the medications lithium and lamotrigine (Lamictal®) in treating
depression in individuals with bipolar II disorder.
Bipolar II disorder (BDII) is a serious condition characterized by depressive and hypomanic
episodes. The disability and suicide risk associated with BDII is equal to bipolar I
disorder. However, there are no clinical trials for BDII, nor is the treatment of BDII
addressed in current treatment guidelines. Data suggest that Li and LTG may be effective
treatment options for BDII. This study will determine the safety, effectiveness, and
tolerability of the two drugs in people with BDII.
Participants in this study will be randomly assigned to receive either Li or LTG for 16
weeks. Participants will be assessed every 2 weeks. One week after study completion,
participants will have a follow-up visit. Measures of depression, mania, quality of life,
functioning, and participant satisfaction will be taken.
- Current diagnosis of bipolar II disorder
- Use of lithium or lamotrigine
- Intolerance to lithium or lamotrigine
- Substance abuse or dependence within the last month
- Suicidal thoughts
- Unstable medical conditions
- Pregnancy or breast-feeding
- Stable on current medications
- Use of fluoxetine (Prozac) within 2 weeks of study
- Require an antipsychotic medication
- Do not speak or read English