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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

September 13, 2005
November 16, 2015
September 1996
July 2003   (final data collection date for primary outcome measure)
MADRS score
Same as current
Complete list of historical versions of study NCT00208702 on ClinicalTrials.gov Archive Site
CGI
Same as current
Not Provided
Not Provided
 
Thyroid Medication and Antidepressants for Treating Major Depression
Thyroid Axis in 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).

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depression
  • Drug: Triiodothyronine
    Other Name: Cytomel
  • Other: Placebo
  • Drug: Sertraline
    Other Name: Zoloft
  • Experimental: sertraline + triiodothyronine
    Interventions:
    • Drug: Triiodothyronine
    • Drug: Sertraline
  • Placebo Comparator: sertraline + placebo
    Interventions:
    • Other: Placebo
    • Drug: Sertraline
Garlow SJ, Dunlop BW, Ninan PT, Nemeroff CB. The combination of triiodothyronine (T3) and sertraline is not superior to sertraline monotherapy in the treatment of major depressive disorder. J Psychiatr Res. 2012 Nov;46(11):1406-13. doi: 10.1016/j.jpsychires.2012.08.009.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
July 2003
July 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00208702
0431-1996, R01MH056946, 431-1996, DSIR AT-SO
No
Not Provided
Not Provided
Boadie W. Dunlop, Emory University
Emory University
National Institute of Mental Health (NIMH)
Principal Investigator: Boadie W Dunlop, MD, MS Emory University
Emory University
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP