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Maintenance Treatment of Bipolar Depression

Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder; Depression

Intervention: Lamotrigine (Drug); Divalproex (DIV) ER (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: The University of Texas Health Science Center at San Antonio

Official(s) and/or principal investigator(s):
Charles L. Bowden, MD, Principal Investigator, Affiliation: 210-567-5405


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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mania Rating Scale

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Additional Information

Starting date: December 2004
Last updated: April 15, 2015

Page last updated: August 23, 2015

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