NCT00158990

Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.

Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (planned)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Major Depression
• Bipolar Disorder
• Unipolar Depression

Interventions

Type	Name	Description
DRUG	triiodothyronine
DRUG	sertraline

Timeline

• Start date: 2002-10-01
• Completion: 2007-07-01
• First posted: 2005-09-12
• Last updated: 2007-01-04

Locations

2 sites across 2 countries: United States, Israel