Thyroid Medication and Antidepressants for Treating Major Depression

Major Depression Clinical Trial

Official title:

Thyroid Axis in Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208702
• Other study ID #: 0431-1996
• Secondary ID: R01MH056946431-1
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: November 16, 2015
• Start date: September 1996
• Est. completion date: July 2003

Study information

• Verified date: November 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: July 2003
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Triiodothyronine

Other:
• Placebo

Drug:
• Sertraline

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.jpsychir — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS score
Secondary	CGI