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Thyroid Medication and Antidepressants for Treating Major Depression

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boadie W. Dunlop, Emory University
ClinicalTrials.gov Identifier:
NCT00208702
First received: September 13, 2005
Last updated: November 16, 2015
Last verified: November 2015
  Purpose
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
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Thyroid Axis in Major Depression

Resource links provided by NLM:


Further study details as provided by Boadie W. Dunlop, 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208702

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

Publications:
Responsible Party: Boadie W. Dunlop, Director, Mood and Anxiety Disorders Program, Emory University
ClinicalTrials.gov Identifier: NCT00208702     History of Changes
Other Study ID Numbers: 0431-1996
R01MH056946 ( U.S. NIH Grant/Contract )
431-1996
DSIR AT-SO
Study First Received: September 13, 2005
Last Updated: November 16, 2015

Keywords provided by Boadie W. Dunlop, Emory University:
Major Depressive Disorder
Mental Health
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2017