Completed

Thyroid Axis in Major Depression

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What is being tested

Triiodothyronine

+ Sertraline

+ Placebo

DrugOther
Who is being recruted

Psychological Well-Being+6

+ Behavior

+ Mental Disorders

From 18 to 60 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: September 1996
See protocol details

Summary

Principal SponsorEmory University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1996

Actual date on which the first participant was enrolled.

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

Official TitleThyroid Axis in Major Depression
NCT00208702
Principal SponsorEmory University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

153 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Psychological Well-BeingBehaviorMental DisordersBehavioral SymptomsDepressionDepressive Disorder, MajorDepressive DisorderPersonal SatisfactionMood Disorders

Criteria

3 inclusion criteria required to participate
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
6 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Emory University

Atlanta, United StatesOpen Emory University in Google Maps
CompletedOne Study Center