Thyroid Medication and Antidepressants for Treating Major Depression

Emory University

Status and phase

Completed

Phase 4

Conditions

Major Depression

Treatments

Drug: Sertraline

Other: Placebo

Drug: Triiodothyronine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00208702

R01MH056946 (U.S. NIH Grant/Contract)

DSIR AT-SO

0431-1996

431-1996

Details and patient eligibility

About

This study will evaluate the effectiveness of treatment with supplemental triiodothyronine (T3, Cytomel) and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), in improving symptoms of major depressive disorder (MDD).

Full description

The primary hypothesis is that triiodothyronine (Cytomel) supplementation of the antidepressant sertraline (Zoloft) will result in a greater improvement in HAM-D scores compared to placebo in the treatment of Major Depressive Disorder (MDD).

The goals of this proposal are to examine the relationship between Major Depressive Disorder (MDD) and abnormalities of the hypothalamic pituitary thyroid (HPT) axis. This protocol will systematically examine the value of supplemental triiodothyronine (T3, Cytomel) with sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI) in the treatment of MDD. The focus will be on two overlapping populations: 1) those with evidence of HPT abnormalities, and 2) those who did not respond to a previous adequate SSRI trial

Enrollment

153 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female between the ages of 18 and 60. (The upper age is limited to 60 because thyroid changes, including blunting of the TSH response to TRH occurs with age and can potentially confound the relationship between the HPT axis and MDD.)
Primary diagnosis of unipolar Major Depressive Disorder
HAM-D (21 item) score >18

Exclusion criteria

Alcohol abuse or alcohol dependence within the past year.
Psychoactive substance abuse or dependence within the past year.
Clinical evidence of severe Personality Disorder that would make study participation and completion unlikely.
ECT within the past 6 months.
Grade I hypothyroidism defined as low thyroid hormone levels with an associated elevated TSH; hyperthyroidism defined as elevated thyroid hormone concentrations with a low TSH.
Serious and unstable medical illnesses.