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

Phase 3

Completed

• Conditions: Major Depression; Bipolar Disorder; Unipolar Depression

• Registration Number: NCT00158990
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Study Timeline

• Study Start: 2002-10
• Status Verified: 2005-08
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Last Update Submitted: 2007-01-02
• Last Update Posted: 2007-01-04
• Study Completion: 2007-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Diagnosis of Major Depressive Episode (MDE) in the context of Bipolar Disorder I or II (BPD-I or BPD-II) or Major Depressive Disorder (UPD), according to DSM-IV criteria, without psychotic features.
2. Hamilton Depression Scale (HAM-D) total >16 with item 1 (depressed mood) >2.
3. Age 18-70 years, male or female.
4. Competent and willing to give written informed consent.

Exclusion Criteria

1. No clinical hyper- or hypothyroidism nor other thyroid illness.
2. No neurological or other physical illness that may impact upon the study or limit prescription of the study medications.
3. No lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
4. No significant suicidal risk (HAM-D item 3 (suicide) <3).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Response - HAM-D-21 improvement >50% at 8 weeks
Remission - final HAM-D-21 total <7 at 8 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of change in HAM-D-21 scores over 8 week treatment period

Trial Locations

Locations (2)

Global Medical Institutes; 🇺🇸 Princeton, New Jersey, United States

Hadassah Medical Organisation; 🇮🇱 Jerusalem, Israel