Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.
The purpose of this project is to determine whether concurrent treatment of patients with major depression (unipolar or bipolar) with triiodothyronine (T3) and sertraline, will lead to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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|