Acute Treatment of Bipolar II Depression

July 19, 2012 updated by: Stanford University
This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390-9121
        • University of Texas Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Lithium
Drug: Lithium
Participants will receive lithium.
Experimental: 2 Lamotrigine
Drug: Lamotrigine
Participants will receive lamotrigine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression
Time Frame: Measured at baseline and Week 16
Measured at baseline and Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of hypomanic and depressive symptoms
Time Frame: Measured at baseline and Week 16
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)
Time Frame: Measured at baseline and Week 16
Measured at baseline and Week 16
Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater
Time Frame: Measured at baseline and Week 16
Measured at baseline and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Trisha Suppes, MD, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

December 19, 2003

First Submitted That Met QC Criteria

December 19, 2003

First Posted (Estimate)

December 22, 2003

Study Record Updates

Last Update Posted (Estimate)

July 23, 2012

Last Update Submitted That Met QC Criteria

July 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21MH067055 (U.S. NIH Grant/Contract)
  • DSIR 83-ATSO (National Institute of Mental Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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