Double-blind randomized controlled study of the efficacy, safety and tolerability of eszopiclone vs placebo for the treatment of patients with post-traumatic stress disorder and insomnia
Sheila M Dowd, Mark H Pollack, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL 60601, United States
Alyson K Zalta, Department of Psychological Science, University of California Irvine, Irvine, CA 92697, United States
Helen J Burgess, Sleep and Circadian Research Laboratory, Department of Psychiatry, University of Michigan, Ann Arbor, MI 48109, United States
Elizabeth C Adkins, Center for Behavioral Intervention Technologies | Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States
Zerbrina Valdespino-Hayden, Department of Psychology, Montclair State University, Montclair, NJ 07043, United States
Author contributions: Pollack MH designed the research; Pollack MH, Dowd SM, Zalta AK, Adkins EC and Valdespino-Hayden Z performed the research; Valdespino-Hayden Z and Burgess HJ scored and analyzed the sleep data; Pollack MH, Dowd SM, Zalta AK, Burgess HJ, Adkins EC and Valdespino-Hayden Z wrote the paper.
Supported by National Institute of Mental Health, No. 5R34MH91338-03 and No. K23 MH103394 (to Zalta AK).
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of Rush University Medical Center.
Clinical trial registration statement: The study was registered on ClinicalTrials.gov. The registration identification number is NCT01605253.
Informed consent statement: Informed consent was obtained prior to the initial assessment.
Conflict-of-interest statement: Dr. Dowd reports grants from NIMH, during the conduct of the study; other from The Wellness Network, grants from Janssen Pharmaceuticals, grants from National Institutes of Health, outside the submitted work.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Sheila M Dowd, PhD, Associate Professor, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, 1645 West Jackson Blvd Suite 400, Chicago, IL 60601, United States. firstname.lastname@example.org
Received: November 13, 2019
Peer-review started: November 13, 2019
First decision: January 15, 2020
Revised: February 10, 2020
Accepted: February 23, 2020
Article in press: February 23, 2020
Published online: March 19, 2020