Acute Treatment of Bipolar II Depression

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by:
Stanford University Identifier:
First received: December 19, 2003
Last updated: July 19, 2012
Last verified: July 2012
This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.

Condition Intervention Phase
Bipolar Disorder
Drug: Lithium
Drug: Lamotrigine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Treatment of Bipolar II Depression

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 102
Study Start Date: May 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Lithium Drug: Lithium
Participants will receive lithium.
Experimental: 2 Lamotrigine Drug: Lamotrigine
Participants will receive lamotrigine.

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.


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00074776

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)
Principal Investigator: Trisha Suppes, MD, PhD Stanford University
  More Information

Responsible Party: Trisha Suppes, MD, PhD, Stanford University Identifier: NCT00074776     History of Changes
Other Study ID Numbers: R21MH067055  DSIR 83-ATSO 
Study First Received: December 19, 2003
Last Updated: July 19, 2012
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
Bipolar Depression

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Antimanic Agents
Antipsychotic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sodium Channel Blockers
Therapeutic Uses
Tranquilizing Agents
Voltage-Gated Sodium Channel Blockers processed this record on April 27, 2016