Michael W Otto1, Mark H Pollack2, Sheila M Dowd2, Stefan G Hofmann1, Godfrey Pearlson3, Kristin L Szuhany1, Ralitza Gueorguieva4, John H Krystal5, Naomi M Simon6, David F Tolin3. 1. Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts. 2. Department of Psychiatry, Rush University Medical Center, Chicago, Illinois. 3. Institute of Living and Yale University School of Medicine, Hartford, Connecticut. 4. Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut. 5. Department of Psychiatry, Yale University School of Medicine and Yale-New Haven Hospital, New Haven, Connecticut. 6. Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Abstract
BACKGROUND: Initial studies have provided a mixed perspective of the efficacy of d-cycloserine (DCS) for augmenting the efficacy of exposure-based cognitive behavioral therapy (CBT) for panic disorder. In this multicenter trial, we examine the magnitude of DCS augmentation effects for an ultra-brief program of CBT. METHODS: We conducted a double-blind, controlled trial at three treatment sites, randomizing 180 adults with a primary diagnosis of panic disorder to five sessions of treatment, withstudy pill (50 mg DCS or matching placebo) administered 1 hr prior to the final three sessions. Two booster sessions were subsequently provided, and outcome was assessed at posttreatment and 1-month, 2-month, and 6-month follow-up assessments. The primary outcome was the degree of reduction in the Panic Disorder Severity Scale. Additional analyses examined the role of severity and current antidepressant or benzodiazepine use as moderators of DCS augmentation effects. RESULTS: DCS augmentation resulted in significant benefit only early in the trial, with no beneficial effects of DCS augmentation evident at follow-up evaluations. We did not find that baseline severity or antidepressant or benzodiazepine use moderated DCS efficacy, but benzodiazepine use was associated with lower efficacy of CBT regardless of augmentation condition. CONCLUSIONS: Consistent with other recent multicenter trials, the benefit of DCS was less than indicated by pilot study and reflected an acceleration of treatment response evident at treatment endpoint, but no advantage in response over follow-up evaluation. Our results did not support severity or concomitant medication moderators observed in previous trials of DCS augmentation.
RCT Entities:
BACKGROUND: Initial studies have provided a mixed perspective of the efficacy of d-cycloserine (DCS) for augmenting the efficacy of exposure-based cognitive behavioral therapy (CBT) for panic disorder. In this multicenter trial, we examine the magnitude of DCS augmentation effects for an ultra-brief program of CBT. METHODS: We conducted a double-blind, controlled trial at three treatment sites, randomizing 180 adults with a primary diagnosis of panic disorder to five sessions of treatment, with study pill (50 mg DCS or matching placebo) administered 1 hr prior to the final three sessions. Two booster sessions were subsequently provided, and outcome was assessed at posttreatment and 1-month, 2-month, and 6-month follow-up assessments. The primary outcome was the degree of reduction in the Panic Disorder Severity Scale. Additional analyses examined the role of severity and current antidepressant or benzodiazepine use as moderators of DCS augmentation effects. RESULTS:DCS augmentation resulted in significant benefit only early in the trial, with no beneficial effects of DCS augmentation evident at follow-up evaluations. We did not find that baseline severity or antidepressant or benzodiazepine use moderated DCS efficacy, but benzodiazepine use was associated with lower efficacy of CBT regardless of augmentation condition. CONCLUSIONS: Consistent with other recent multicenter trials, the benefit of DCS was less than indicated by pilot study and reflected an acceleration of treatment response evident at treatment endpoint, but no advantage in response over follow-up evaluation. Our results did not support severity or concomitant medication moderators observed in previous trials of DCS augmentation.
Authors: M K Shear; T A Brown; D H Barlow; R Money; D E Sholomskas; S W Woods; J M Gorman; L A Papp Journal: Am J Psychiatry Date: 1997-11 Impact factor: 18.112
Authors: S G Hofmann; D H Barlow; L A Papp; M F Detweiler; S E Ray; M K Shear; S W Woods; J M Gorman Journal: Am J Psychiatry Date: 1998-01 Impact factor: 18.112
Authors: Jasper A J Smits; David Rosenfield; Michael W Otto; Luana Marques; Michelle L Davis; Alicia E Meuret; Naomi M Simon; Mark H Pollack; Stefan G Hofmann Journal: J Psychiatr Res Date: 2013-07-16 Impact factor: 4.791
Authors: Nesha S Burghardt; Torfi Sigurdsson; Jack M Gorman; Bruce S McEwen; Joseph E LeDoux Journal: Biol Psychiatry Date: 2012-12-20 Impact factor: 13.382
Authors: Jasper A J Smits; Michael J Zvolensky; Michael W Otto; Megan E Piper; Scarlett O Baird; Brooke Y Kauffman; Eunjung Lee-Furman; Noura Alavi; Christina D Dutcher; Santiago Papini; Benjamin Rosenfield; David Rosenfield Journal: Drug Alcohol Depend Date: 2020-01-22 Impact factor: 4.492
Authors: David Rosenfield; Jasper A J Smits; Stefan G Hofmann; David Mataix-Cols; Lorena Fernández de la Cruz; Erik Andersson; Christian Rück; Benedetta Monzani; Ana Pérez-Vigil; Paolo Frumento; Michael Davis; Rianne A de Kleine; JoAnn Difede; Boadie W Dunlop; Lara J Farrell; Daniel Geller; Maryrose Gerardi; Adam J Guastella; Gert-Jan Hendriks; Matt G Kushner; Francis S Lee; Eric J Lenze; Cheri A Levinson; Harry McConnell; Jens Plag; Mark H Pollack; Kerry J Ressler; Thomas L Rodebaugh; Barbara O Rothbaum; Eric A Storch; Andreas Ströhle; Candyce D Tart; David F Tolin; Agnes van Minnen; Allison M Waters; Carl F Weems; Sabine Wilhelm; Katarzyna Wyka; Margaret Altemus; Page Anderson; Judith Cukor; Claudia Finck; Gary R Geffken; Fabian Golfels; Wayne K Goodman; Cassidy A Gutner; Isobel Heyman; Tanja Jovanovic; Adam B Lewin; Joseph P McNamara; Tanya K Murphy; Seth Norrholm; Paul Thuras; Cynthia Turner; Michael W Otto Journal: J Anxiety Disord Date: 2019-09-23