Expired Study
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Dallas, Texas 75390


Purpose:

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


Study summary:

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.


Criteria:

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


NCT ID:

NCT00074776


Primary Contact:

Principal Investigator
Trisha Suppes, MD, PhD
Stanford University


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75390
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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