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Maintenance Treatment of Bipolar Depression

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Maintenance Treatment of Bipolar Depression
Official Title  Eight-Month Maintenance Treatment of Bipolar Depression With Lamotrigine or Lamotrigine Plus Divalproex Combination
Brief Summary

This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.

Detailed Description

Depression is a serious condition that is often difficult to diagnosis and treat. Bipolar disorder-related depression is especially complex because of the presence of mania symptoms. Lamotrigine and divalproex are commonly prescribed medications for depression. However, their effectiveness in treating bipolar depression has not been thoroughly evaluated. Studies have shown that combining lamotrigine with another antidepressant may be more effective in reducing depressive symptoms than lamotrigine alone. This study will provide participants with either lamotrigine alone or in combination with divalproex and will determine which regimen is more effective in reducing symptoms of bipolar depression.

Participants will be randomly assigned to a daily regimen of either lamotrigine and divalproex or lamotrigine and placebo for 8 months. Participants will be assessed at study entry, at two unspecified times during the study, and at the end of the study. During each assessment, participants will undergo a brief interview and complete a questionnaire about their depressive symptoms, any physical manifestations of their depression, and their overall level of functioning in daily activities.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Rates of response to treatment regimen [ Time Frame: Measured at Week 32 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure 
Condition  Bipolar Disorder
Depression
Intervention  Drug: Lamotrigine (LAM)
Drug: Divalproex (DIV)
Drug: Placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  170
Start Date  December 2004
Completion Date June 2008
Eligibility Criteria 

Inclusion Criteria:

  • Diagnosis of bipolar disorder I or II
  • Experiencing symptoms of depression at study entry OR have experienced symptoms of depression within 6 months prior to study entry
  • Willing to use acceptable methods of contraception
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

  • History of liver disease
  • History of substance abuse
  • Previous treatment with lamotrigine or divalproex
  • Lamotrigine or divalproex intolerance
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Martha L. Dahl, RN     210-567-5501     dahlml@uthscsa.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00183469
Organization ID P20 MH68662
Secondary IDs †† DSIR 83-ATSO
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Charles L. Bowden, MD     210-567-5405    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  September 13, 2005
Last Updated Date February 12, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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