Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.
|Major Depression Bipolar Disorder Unipolar Depression||Drug: triiodothyronine Drug: sertraline||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.|
- 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
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||July 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|