Thyroid Medication and Antidepressants for Treating Major Depression

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boadie W. Dunlop, Emory University Identifier:
First received: September 13, 2005
Last updated: November 16, 2015
Last verified: November 2015
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).

Condition Intervention Phase
Major Depression
Drug: Triiodothyronine
Other: Placebo
Drug: Sertraline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Thyroid Axis in Major Depression

Resource links provided by NLM:

Further study details as provided by Emory University:

Primary Outcome Measures:
  • MADRS score

Secondary Outcome Measures:
  • CGI

Enrollment: 153
Study Start Date: September 1996
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sertraline + triiodothyronine Drug: Triiodothyronine
Other Name: Cytomel
Drug: Sertraline
Other Name: Zoloft
Placebo Comparator: sertraline + placebo Other: Placebo Drug: Sertraline
Other Name: Zoloft

Detailed 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


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00208702

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Principal Investigator: Boadie W Dunlop, MD, MS Emory University
  More Information

Responsible Party: Boadie W. Dunlop, Director, Mood and Anxiety Disorders Program, Emory University Identifier: NCT00208702     History of Changes
Other Study ID Numbers: 0431-1996  R01MH056946  431-1996  DSIR AT-SO 
Study First Received: September 13, 2005
Last Updated: November 16, 2015
Health Authority: United States: Federal Government

Keywords provided by Emory University:
Major Depressive Disorder
Mental Health

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses processed this record on February 07, 2016