Back to results

Acute Treatment of Bipolar II Depression

Primary Purpose

Bipolar Disorder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Lithium

Lamotrigine

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Depression

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Texas Southwestern Medical Center at Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

1 Lithium

2 Lamotrigine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence and severity of hypomanic and depressive symptoms

Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12)

Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater

Full Information

NCT ID

NCT00074776

First Posted

December 19, 2003

Last Updated

July 19, 2012

Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00074776

Brief Title

Acute Treatment of Bipolar II Depression

Official Title

Acute Treatment of Bipolar II Depression

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

Keywords

Bipolar Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 Lithium

Arm Type

Experimental

Arm Title

2 Lamotrigine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Lithium

Intervention Description

Participants will receive lithium.

Intervention Type

Drug

Intervention Name(s)

Lamotrigine

Intervention Description

Participants will receive lamotrigine.

Primary Outcome Measure Information:

Title

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

Time Frame

Measured at baseline and Week 16

Secondary Outcome Measure Information:

Title

Incidence and severity of hypomanic and depressive symptoms

Time Frame

Measured at baseline and Week 16

Title

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

Title

Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater

Time Frame

Measured at baseline and Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Trisha Suppes, MD, PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Southwestern Medical Center at Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9121

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18358540

Citation

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. doi: 10.1016/j.jad.2008.02.004. Epub 2008 Mar 20.

Results Reference

result

Learn more about this trial

Acute Treatment of Bipolar II Depression

We'll reach out to this number within 24 hrs