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Acute Treatment of Bipolar II Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00074776
Recruitment Status : Completed
First Posted : December 22, 2003
Last Update Posted : July 23, 2012
National Institute of Mental Health (NIMH)
Information provided by:
Stanford University

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lithium Drug: Lamotrigine Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Treatment of Bipolar II Depression
Study Start Date : May 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Lithium Drug: Lithium
Participants will receive lithium.

Experimental: 2 Lamotrigine Drug: Lamotrigine
Participants will receive lamotrigine.

Primary Outcome Measures :
  1. Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression [ Time Frame: Measured at baseline and Week 16 ]

Secondary Outcome Measures :
  1. Incidence and severity of hypomanic and depressive symptoms [ Time Frame: Measured at baseline and Week 16 ]
  2. 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 ]
  3. Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater [ Time Frame: Measured at baseline and Week 16 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00074776

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United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-9121
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
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Principal Investigator: Trisha Suppes, MD, PhD Stanford University

Publications of Results:
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Responsible Party: Trisha Suppes, MD, PhD, Stanford University Identifier: NCT00074776     History of Changes
Other Study ID Numbers: R21MH067055 ( U.S. NIH Grant/Contract )
R21MH067055 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2003    Key Record Dates
Last Update Posted: July 23, 2012
Last Verified: July 2012

Keywords provided by Stanford University:
Bipolar Depression

Additional relevant MeSH terms:
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Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Antipsychotic Agents
Sodium Channel Blockers