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| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | June 30, 2009 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Rates of response to treatment regimen [ Time Frame: Measured at Week 32 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Rates of response to treatment regimen | ||||
| Change History | Complete list of historical versions of study NCT00183469 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Maintenance Treatment of Bipolar Depression | ||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 170 | ||||
| Completion Date | April 2009 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00183469 | ||||
| Responsible Party | Charles L. Bowden, University of Texas Health Science Center at SanAntonio | ||||
| Study ID Numbers ICMJE | P20 MH68662, DSIR 83-ATSO | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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