Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
102 participants
INTERVENTIONAL
2003-05-31
2007-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1 Lithium
Lithium
Participants will receive lithium.
2 Lamotrigine
Lamotrigine
Participants will receive lamotrigine.
Interventions
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Lithium
Participants will receive lithium.
Lamotrigine
Participants will receive lamotrigine.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Stanford University
OTHER
Responsible Party
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Stanford University
Principal Investigators
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Trisha Suppes, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Countries
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References
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Suppes T, Marangell LB, Bernstein IH, Kelly DI, Fischer EG, Zboyan HA, Snow DE, Martinez M, Al Jurdi R, Shivakumar G, Sureddi S, Gonzalez R. A single blind comparison of lithium and lamotrigine for the treatment of bipolar II depression. J Affect Disord. 2008 Dec;111(2-3):334-43. doi: 10.1016/j.jad.2008.02.004. Epub 2008 Mar 20.
Other Identifiers
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