Acute Treatment of Bipolar II Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

December 19, 2003

Last Updated Date

April 14, 2009

Start Date ^ICMJE

May 2003

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00074776 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Acute Treatment of Bipolar II Depression

Official Title ^ICMJE

Acute Treatment of Bipolar II Depression

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: Lithium
Drug: Lamotrigine

Study Arms / Comparison Groups

Publications *

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. Epub 2008 Mar 20.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

102

Completion Date

October 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00074776

Responsible Party

Trisha Suppes, MD, PhD, Stanford University

Study ID Numbers ^ICMJE

R21 MH067055, DSIR 83-ATSO

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Trisha Suppes, MD, PhD

Stanford University

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP