ClinicalTrials.gov
ClinicalTrials.gov Menu

Thyroid Medication and Antidepressants for Treating Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00208702
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boadie W. Dunlop, Emory University

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depression Drug: Triiodothyronine Other: Placebo Drug: Sertraline Phase 4

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Thyroid Axis in Major Depression
Study Start Date : September 1996
Actual Primary Completion Date : July 2003
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: sertraline + triiodothyronine Drug: Triiodothyronine
Other Name: Cytomel
Drug: Sertraline
Other Name: Zoloft
Placebo Comparator: sertraline + placebo Other: Placebo Drug: Sertraline
Other Name: Zoloft



Primary Outcome Measures :
  1. MADRS score

Secondary Outcome Measures :
  1. CGI


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 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