Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.
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|ClinicalTrials.gov Identifier: NCT00158990|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 4, 2007
|Condition or disease||Intervention/treatment||Phase|
|Major Depression Bipolar Disorder Unipolar Depression||Drug: triiodothyronine Drug: sertraline||Phase 3|
AIM: To determine the therapeutic efficacy and adverse effects of triiodothyronine (T3) as a supplement to the treatment of bipolar depression (BPD) with a mood stabilizer (MS) (lithium - Li, valproic acid - VPA or carbamazepine - CBZ) and the specific serotonin reuptake inhibitor (SSRI), sertraline; and as a supplement to the treatment of unipolar depression (UPD) with sertraline.
METHOD: A random assignment, double blind, placebo-controlled trial separately evaluating patients with a) BPD who are treated with MS + sertraline + T3 or MS + sertraline + placebo and b) UPD who are treated with sertraline + T3 or sertraline + placebo, for up to 8 weeks in both cases. The design of the trial will permit both the outcome of treatment and the speed of response to be evaluated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.|
|Study Start Date :||October 2002|
|Estimated Study Completion Date :||July 2007|
- Response - HAM-D-21 improvement >50% at 8 weeks
- Remission - final HAM-D-21 total <7 at 8 weeks
- Rate of change in HAM-D-21 scores over 8 week treatment period
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): NCT00158990
|United States, New Jersey|
|Global Medical Institutes|
|Princeton, New Jersey, United States, 08540|
|Hadassah Medical Organisation|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Bernard Lerer, MD||hadassah medical organisation|