The combination of triiodothyronine (T3) and sertraline is not superior to sertraline monotherapy in the treatment of major depressive disorder

• Type of Material: Article
• Authors: Steven Garlow, Emory University; Boadie W Dunlop, Emory University; Philip T. Ninan, Pfizer Pharmaceuticals Inc; Charles B. Nemeroff, University of Miami
• Language: English
• Date: 2012-11
• Publisher: Elsevier
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2012 Elsevier Ltd. All rights reserved.
• License: Creative Commons Attribution-NonCommerical-NoDerivs 3.0 Unported
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jpsychires.2012.08.009
• Title of Journal or Parent Work: Journal of Psychiatric Research
• ISSN: 0022-3956
• Volume: 46
• Issue: 11
• Start Page: 1406
• End Page: 1413
• Grant/Funding Information: Dr. Dunlop has received research support from Evotec, Forest, GSK, NIMH, Novartis, Ono, Pfizer.; Dr. Nemeroff has grants/research from Abbott Laboratories; AFSP; AstraZeneca; Bristol-Myers-Squibb; Eli Lilly; Forest Laboratories; GlaxoSmithKline; Janssen Pharmaceutica; Merck; NARSAD; NIMH; Pfizer Pharmaceuticals; Stanley Foundation/NAMI; Wyeth-Ayerst.; This research funded by K23 RR15531-01 (SJG), RO1 MH56946 (PTN), K23 MH 086690 (BWD) and UL1 RR025008 (Emory University).; Steven J. Garlow was a significant source of funding in the completion of the study; Dr. Garlow receives research support from Dana Foundation and also has received research support from Janssen Pharmaceuticals.
• Keywords: Depression; Remission; Antidepressants; Triiodothyronine; Augmentation; Response
• Research Categories: Health Sciences, Mental Health; Psychology, Behavioral; Chemistry, Pharmaceutical

Abstract

Objective To determine whether the combination of triiodothyronine (T3) plus sertraline at treatment initiation confers greater antidepressant efficacy than sertraline plus placebo in patients with major depressive disorder. Method Eight-week, double blind, randomized placebo controlled clinical trial of 153 adult outpatients between 18 and 60 years of age, with DSM-IV defined major depressive disorder. Patients were treated with sertraline flexibly adjusted for tolerability and in a double blind fashion with placebo or T3 (25 μg/day in week 1 and increasing to 50 μg/day in week 2). Response was defined categorically as 50% reduction and total score less than 15 in 21-item Hamilton Rating Scale for Depression (HRSD-21) at week 8 and remission as HRSD-21 less than 8. Results There was no difference between treatment groups at final assessment; 65% of placebo and 61.8% of T3 treated subjects achieved response and 50.6% of placebo and 40.8% of T3 treated patients achieved remission. The mean daily dose at final assessment of sertraline and T3, respectively was 144.7 mg (±48.7 mg) and 48.2 μg (±7 μg). Median time to response did not differ between treatment groups. Baseline thyroid function tests did not predict response to sertraline treatment or T3 augmentation. Conclusions These results do not support the routine use of T3 to enhance or accelerate onset of antidepressant response in patients with major depressive disorder.