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OpenTrials
Completed

NCT Number: NCT00074776

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390-9121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lithium

Drug

Participants will receive lithium.

Lamotrigine

Drug

Participants will receive lamotrigine.

Primary outcomes

  1. Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression

    Time frame: Measured at baseline and Week 16

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Dec 22, 2003
Registry last updated
Jul 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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