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

Condition(s) targeted: Major Depression; Bipolar Disorder; Unipolar Depression

Intervention: triiodothyronine (Drug); sertraline (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hadassah Medical Organization

Official(s) and/or principal investigator(s):
Bernard Lerer, MD, Principal Investigator, Affiliation: Hadassah - Medical Organisation

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Response - HAM-D-21 improvement >50% at 8 weeks

Remission - final HAM-D-21 total <7 at 8 weeks

Secondary outcome: Rate of change in HAM-D-21 scores over 8 week treatment period

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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).

Hadassah Medical Organisation, Jerusalem 91120, Israel

Global Medical Institutes, Princeton, New Jersey 08540, United States

Starting date: October 2002
Ending date: July 2007
Last updated: January 2, 2007