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Acute Treatment of Bipolar II Depression

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00074776
First received: December 19, 2003
Last updated: July 19, 2012
Last verified: July 2012
History of Changes

December 19, 2003
July 19, 2012
May 2003
October 2007   (final data collection date for primary outcome measure)
Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00074776 on ClinicalTrials.gov Archive Site
  • Incidence and severity of hypomanic and depressive symptoms [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]
  • Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12) [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]
  • Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Acute Treatment of Bipolar II Depression
Acute Treatment of Bipolar II Depression

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Lithium
    Participants will receive lithium.
  • Drug: Lamotrigine
    Participants will receive lamotrigine.
  • Experimental: 1 Lithium
    Intervention: Drug: Lithium
  • Experimental: 2 Lamotrigine
    Intervention: Drug: Lamotrigine
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. Epub 2008 Mar 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00074776
R21 MH067055, R21MH067055, DSIR 83-ATSO
Yes
Trisha Suppes, MD, PhD, Stanford University
Stanford University
National Institute of Mental Health (NIMH)
Principal Investigator: Trisha Suppes, MD, PhD Stanford University
Stanford University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP