Acute Treatment of Bipolar II Depression
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|ClinicalTrials.gov Identifier: NCT00074776|
Recruitment Status : Completed
First Posted : December 22, 2003
Last Update Posted : July 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Lithium Drug: Lamotrigine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acute Treatment of Bipolar II Depression|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
|Experimental: 1 Lithium||
Participants will receive lithium.
|Experimental: 2 Lamotrigine||
Participants will receive lamotrigine.
- Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression [ Time Frame: Measured at baseline and Week 16 ]
- Incidence and severity of hypomanic and depressive symptoms [ Time Frame: Measured at baseline and Week 16 ]
- Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12) [ Time Frame: Measured at baseline and Week 16 ]
- Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater [ Time Frame: Measured at baseline and Week 16 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074776
|United States, Texas|
|University of Texas Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390-9121|
|Principal Investigator:||Trisha Suppes, MD, PhD||Stanford University|