TY - JOUR
T1 - Tolerability of the dexamethasone-corticotropin releasing hormone test in major depressive disorder
AU - Dunlop, Boadie W.
AU - Betancourt, Yara
AU - Binder, Elisabeth B.
AU - Heim, Christine
AU - Holsboer, Florian
AU - Ising, Marcus
AU - McKenzie, Melissa
AU - Mletzko, Tanja
AU - Pfister, Hildegard
AU - Nemeroff, Charles B.
AU - Craighead, W. Edward
AU - Mayberg, Helen S.
N1 - Funding Information:
Ms. Betancourt, Dr. Ising, Ms. McKenzie, Ms. Mletzko and Ms. Pfister report no financial disclosures. Dr. Binder receives grant support from NIMH, the Doris Duke Charitable Foundation and from PharmaNeuroBoost. Dr. Craighead reports ownership in Novadel stock, and serving on the Board of Directors for Hugaheilll elf, and Icelandic non-profit company. Dr. Dunlop reports research support from AstraZeneca, Forest, GSK, NIH, Novartis, Ono Pharmaceuticals, Takeda, and Wyeth. He has performed consulting with Digitas Health, Imedex LLC and MedAvante. 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). Dr. Holsboer reports grant support from the German Ministry of Research and Education, and is a founder and share holder of Affectis Pharmaceuticals. Dr. Mayberg receives research support from the NIH, consults to Advanced Neuromodulation Systems, and is an intellectual property holder and licensor in the field of Deep Brain Stimulation. Dr. Nemeroff has served on the scientific advisory boards of American Foundation for Suicide Prevention (AFSP); AstraZeneca; Forest Laboratories; NARSAD; Quintiles; Janssen/Ortho-McNeil, PharmaNeuroboost, and Mt. Cook Pharma, Inc. He holds stock/equity in Corcept; Revaax; NovaDel Pharma; CeNeRx, and PharmaNeuroboost. He is on the board of directors of the AFSP; George West Mental Health Foundation; NovaDel Pharma, and Mt. Cook Pharma, Inc. Dr. Nemeroff holds a patent on the method and devices for transdermal delivery of lithium (US 6,375,990 B1) and the method to estimate serotonin and norepinephrine transporter occupancy after drug treatment using patient or animal serum (provisional filing April, 2001).
Funding Information:
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. None of the funding sources had a role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the manuscript for publication.
PY - 2011/1
Y1 - 2011/1
N2 - 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 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%) 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.
AB - 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 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%) 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.
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U2 - 10.1016/j.jpsychires.2010.04.020
DO - 10.1016/j.jpsychires.2010.04.020
M3 - Article
C2 - 20488460
AN - SCOPUS:78650953066
VL - 45
SP - 24
EP - 28
JO - Journal of Psychiatric Research
JF - Journal of Psychiatric Research
SN - 0022-3956
IS - 1
ER -