Tolerability of the Dexamethasone-Corticotropin Releasing Hormone Test in Major Depressive Disorder

• Type of Material: Article
• Authors: Boadie W Dunlop, Emory University; Yara Betancourt, Emory University; Elisabeth B. Binder, Emory University; Christine Heim, Emory University; Florian Holsboer, Max Planck Institute of Psychiatry; Marcus Ising, Max Planck Institute of Psychiatry; Melissa McKenzie, Emory University; Tanja Mletzko, Emory University; Hildegard Pfister, Max Planck Institute of Psychiatry; Charles B. Nemeroff, University of Miami; W Edward Craighead, Emory University; Helen S Mayberg, Emory University
• Language: English
• Date: 2011-01
• Publisher: Elsevier
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2010 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.2010.04.020
• Title of Journal or Parent Work: Journal of Psychiatric Research
• ISSN: 0022-3956
• Volume: 45
• Issue: 1
• Start Page: 24
• End Page: 28
• Grant/Funding Information: Dr. Mayberg receives research support from the NIH; Dr. Dunlop reports research support from AstraZeneca, Forest, GSK, NIH, Novartis, Ono Pharmaceuticals, Takeda, and Wyeth.; Dr. Heim reports research support from NARSAD, Anxiety Disorders Association of America (ADAA), Eli Lilly, National Institute of Mental Health (NIMH), and the Center for Disease Control (CDC).; This research was supported in part by the funding from the Bavarian Ministry of Commerce, the Excellence Foundation for the Advancement of the Max Planck Society, NARSAD (C.H., 2002 Young Investigator Award) and the following NIH grants: P50 MH77083, MH-80880, MH-58922, M01-RR00039, 1KL2-RR025009, 1K23 MH086690, UL1-RR025008, M01-RR0039.; Dr. Holsboer reports grant support from the German Ministry of Research and Education; Dr. Binder receives grant support from NIMH, the Doris Duke Charitable Foundation and from PharmaNeuroBoost.
• Keywords: electrocardiogram; corticotropin releasing factor; adverse event; predictor; HPA axis; Cortisol
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, Mental Health; Psychology, General

Abstract

Background The dexamethasone-corticotropin releasing hormone (Dex-CRH) test may differentially predict which depressed patients will respond to antidepressant medication. However, a comprehensive analysis of the safety of this test in psychiatric patients has not been previously been performed. Methods We conducted a pooled analysis of depressed patients in four clinical studies. Observed and subjectively reported side effects in 454 patients were collected for 90 minutes following CRH administration. Pre-test electrocardiograms were available in 250 patients to assess cardiac safety. Descriptive statistics were performed to evaluate these safety data. Results Eight-six (18.9%) of all subjects experienced no side effects from the procedure. The mean number of side effects per subject was 1.4 ± 1.0. The most frequent adverse events were: flushing (n=216, 47.6%), feeling of warmth (144, 31.7%), hyperpnea/tachypnea (108, 23.8%), palpitations (37, 8.1%), and tachycardia (28, 6.2%). Side effects were consistently mild and brief in duration. There were no serious adverse events. Conclusion The Dex-CRH test produces a mild, predictable side-effect profile, characterized by flushing, feelings of warmth, hyperpnea/tachypnea, palpitations, and tachycardia. These results provide reassurance that the Dex-CRH test is well tolerated in psychiatric patients.