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Thyroid Medication and Antidepressants for Treating Major Depression

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00208702
First received: September 13, 2005
Last updated: February 22, 2006
Last verified: September 2005
History of Changes

September 13, 2005
February 22, 2006
September 1996
Not Provided
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
Primary Purpose: Treatment
Major Depression
Drug: Sertraline & Cytomel
Not Provided
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. Epub 2012 Sep 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2003
Not Provided

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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00208702
RO1 MH56946, 431-1996, DSIR AT-SO
Not Provided
Not Provided
National Institute of Mental Health (NIMH)
Emory University
Principal Investigator: Philip T Ninan, MD Emory University
National Institute of Mental Health (NIMH)
September 2005

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