Acute Treatment of Bipolar II Depression
2 other identifiers
interventional
102
1 country
1
Brief Summary
This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2003
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 19, 2003
CompletedFirst Posted
Study publicly available on registry
December 22, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedJuly 23, 2012
July 1, 2012
4.4 years
December 19, 2003
July 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression
Measured at baseline and Week 16
Secondary Outcomes (3)
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
Study Arms (2)
1 Lithium
EXPERIMENTAL2 Lamotrigine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Current diagnosis of bipolar II disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9121, United States
Related Publications (1)
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.
PMID: 18358540RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Trisha Suppes, MD, PhD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 19, 2003
First Posted
December 22, 2003
Study Start
May 1, 2003
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
July 23, 2012
Record last verified: 2012-07