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Clinical Trial: Acute Treatment of Bipolar II Depression
This study is currently recruiting patients.
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Purpose
The purpose of this study is to compare the medications lithium (Li) and lamotrigine (LTG) in treating depression in individuals with bipolar II disorder.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Bipolar Depression | Drug: Lithium Drug: Lamotrigine | Phase III |
MedlinePlus related topics: Bipolar Disorder
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Expected Total Enrollment: 60
Study start: May 2003
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.
Eligibility
Ages Eligible for Study: 18 Years - 55 Years, Genders Eligible for Study: Both
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
Location and Contact Information
Texas
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, 75390, United States; Recruiting
Eileen G Fischer, BS 214-648-6920 eileen.fischer@utsouthwestern.edu
Trisha Suppes, MD, PhD, Principal Investigator
More Information
Record last reviewed: October 2004
Last Updated: October 13, 2004
Record first received: December 19, 2003
ClinicalTrials.gov Identifier: NCT00074776
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
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