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Completed

NCT Number: NCT00208702

Thyroid Medication and Antidepressants for Treating Major Depression

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University

Atlanta, Georgia, 30329, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triiodothyronine

Drug

Other names: Cytomel

Placebo

Other

Sertraline

Drug

Other names: Zoloft

Primary outcomes

  1. MADRS score

Secondary outcomes

  1. CGI

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Thyroid Axis in Major Depression

Important dates

Study start
1996
Primary completion
2003
Study completion
2003
First posted
Sep 21, 2005
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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