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Thyroid Medication and Antidepressants for Treating Major Depression

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depression

Intervention: sertraline + triiodothyronine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Boadie W Dunlop, MD, MS, Principal Investigator, Affiliation: Emory University

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).

Clinical Details

Official title: Thyroid Axis in Major Depression

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

Primary outcome: MADRS score

Secondary outcome: CGI

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

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

Emory University, Atlanta, Georgia 30329, United States
Additional Information

Starting date: September 1996
Last updated: November 22, 2013

Page last updated: August 23, 2015

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