Acute Treatment of Bipolar II Depression - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00074776

Purpose

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Acute Treatment of Bipolar II Depression

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Lamotrigine Lithium carbonate Lithium citrate

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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
1 Lithium: Experimental	Drug: Lithium Participants will receive lithium.
2 Lamotrigine: Experimental	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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074776

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Trisha Suppes, MD, PhD

Stanford University

More Information

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.

Responsible Party:	Stanford University ( Trisha Suppes, MD, PhD )
Study ID Numbers:	R21 MH067055, DSIR 83-ATSO
Study First Received:	December 19, 2003
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00074776 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Bipolar Depression

Additional relevant MeSH terms:

Depression
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Depressive Disorder
Antipsychotic Agents

Pharmacologic Actions
Behavioral Symptoms
Membrane Transport Modulators
Affective Disorders, Psychotic
Mental Disorders
Therapeutic Uses
Mood Disorders
Lamotrigine
Central Nervous System Agents
Anticonvulsants
Lithium

ClinicalTrials.gov processed this record on November 27, 2009