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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


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
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