Maintenance Treatment of Bipolar Depression
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Depression
Intervention: Lamotrigine (LAM) (Drug); Divalproex (DIV) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Charles L. Bowden, MD, Principal Investigator, Affiliation: 210-567-5405
Overall contact:
Martha L. Dahl, RN, Phone: 210-567-5501, Email: dahlml@uthscsa.edu
Summary
This study will compare two different antidepressant treatment regimens to determine which is
more effective in reducing symptoms of bipolar depression.
Clinical Details
Official title: Eight-Month Maintenance Treatment of Bipolar Depression With Lamotrigine or Lamotrigine Plus Divalproex Combination
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Rates of response to treatment regimen
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Martha L. Dahl, RN, Phone: 210-567-5501, Email: dahlml@uthscsa.edu
Department of Psychiatry, University of Texas Health Science Center, San Antonio, Texas 78229, United States; Recruiting
Martha Dahl, RN, Phone: 210-567-5501, Email: dahlm@uthscsa.edu
Charles L. Bowden, MD, Phone: 210-567-5405, Email: bowdenc@uthscsa.edu
Vivek Singh, MD, Sub-Investigator
Additional Information
Starting date: December 2004
Ending date: June 2008
Last updated: February 12, 2008
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