Acute Treatment of Bipolar II Depression

Study Overview
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Brief Summary
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This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.

Detailed Description
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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.

Official Title
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Acute Treatment of Bipolar II Depression

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Lithium
* Drug: Lamotrigine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current diagnosis of bipolar II disorder Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Lithium<br> | Drug: Lithium<br>* Participants will receive lithium.<br>|
| Experimental: 2 Lamotrigine<br> | Drug: Lamotrigine<br>* Participants will receive lamotrigine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression |  | Measured at baseline and Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of hypomanic and depressive symptoms |  | Measured at baseline and Week 16 | 
| Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12) |  | Measured at baseline and Week 16 | 
| Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater |  | Measured at baseline and Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Depression