Acute Treatment of Bipolar II Depression

Bipolar Disorder Clinical Trial

Official title:

Acute Treatment of Bipolar II Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074776
• Other study ID #: R21MH067055
• Secondary ID: R21MH067055DSIR
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2003
• Last updated: July 19, 2012
• Start date: May 2003
• Est. completion date: October 2007

Study information

• Verified date: July 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Lithium
Participants will receive lithium.
• Lamotrigine
Participants will receive lamotrigine.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression		Measured at baseline and Week 16	No
Secondary	Incidence and severity of hypomanic and depressive symptoms		Measured at baseline and Week 16	No
Secondary	Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12)		Measured at baseline and Week 16	No
Secondary	Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater		Measured at baseline and Week 16	No