Child/Adolescent Anxiety Multimodal Study: Evaluating Safety - 25/02/15
, John T. Walkup, MD b, Scott N. Compton, PhD c, Dara J. Sakolsky, MD, PhD d, Joel T. Sherrill, PhD e, Sa Shen, PhD f, Philip C. Kendall, PhD g, James McCracken, MD h, Anne Marie Albano, PhD a, John Piacentini, PhD h, Mark A. Riddle, MD i, Courtney Keeton, PhD i, Bruce Waslick, MD j, Allan Chrisman, MD c, Satish Iyengar, PhD d, John S. March, MD, MPH c, Boris Birmaher, MD dAbstract |
Objective |
To evaluate the frequency of adverse events (AEs) across 4 treatment conditions in the Child/Adolescent Anxiety Multimodal Study (CAMS), and to compare the frequency of AEs between children and adolescents.
Method |
Participants ages 7 to 17 years (mean = 10.7 years) meeting the DSM-IV criteria for 1 or more of the following disorders: separation anxiety disorder, generalized anxiety disorder, or social phobia were randomized (2:2:2:1) to cognitive-behavioral therapy (CBT, n = 139), sertraline (SRT, n = 133), a combination of both (COMB, n = 140), or pill placebo (PBO, n = 76). Data on AEs were collected via a standardized inquiry method plus a self-report Physical Symptom Checklist (PSC).
Results |
There were no differences between the double-blinded conditions (SRT versus PBO) for total physical and psychiatric AEs or any individual physical or psychiatric AEs. The rates of total physical AEs were greater in the SRT-alone treatment condition when compared to CBT (p < .01) and COMB (p < .01). Moreover, those who received SRT alone reported higher rates of several physical AEs when compared to COMB and CBT. The rate of total psychiatric AEs was higher in children (≤12 years) across all arms (31.7% versus 23.1%, p < .05). Total PSC scores decreased over time, with no significant differences between treatment groups.
Conclusion |
The results support the tolerability/safety of selective serotonin reuptake inhibitor (SSRI) treatment for anxiety disorders even after adjusting for the number of reporting opportunities, leading to no differences in overall rates of AEs. Few differences occurred on specific items. Additional monitoring of psychiatric AEs is recommended in children (≤12 years).
Clinical trial registration information—Child and Adolescent Anxiety Disorders (CAMS); clinicaltrials.gov; NCT00052078.
Le texte complet de cet article est disponible en PDF.Key Words : anxiety, adverse events, selective serotonin reuptake inhibitors
Plan
| This article is discussed in an editorial by Dr. Floyd R. Sallee on page 162. |
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| This article was reviewed under and accepted by ad hoc editor Daniel S. Pine, MD. |
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| This research was supported by NIMH grants U01 MH64088 (J.P.), U01 MH064003 (S.C.), U01 MH63747 (P.K.), U01 MH64003 (B.B.), U01 MH64092 (A.M.A.), U01 MH64107 (J.M.), and U01 MH064089 (J.W.). Sertraline and matching placebo were supplied free of charge by Pfizer. |
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| Drs. Iyengar, Shen, and Compton served as the statistical experts for this research. |
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| Disclosure: Dr. Rynn has received research support from NIH, NIMH, the National Institute of Child Health and Human Development (NICHD), Eli Lilly and Co., Pfizer, Merck, and Shire. She has served as a consultant to Shire and has received royalties from American Psychiatric Publishing and a writing fee from Oxford University Press. She has received honoraria from the American Academy of Child and Adolescent Psychiatry (AACAP) and the American Society of Clinical Psychopharmacology (ASCP) workshop for pediatric clinical trials. She has received fees for academic lectures and Grand Rounds. Dr. Walkup has received grant support from the Hartwell Foundation and the Tourette Syndrome Association. He has served as a consultant to Shire. He has received free medication and placebo from Eli Lilly and Co., Pfizer, and Abbott for NIMH-funded studies. He has served on the advisory board and speakers’ bureau of the Tourette Syndrome Association. He has received royalties from Guilford Press and Oxford University Press for books on Tourette syndrome. He has received an honorarium and travel support for an educational meeting from the Tourette Syndrome Association. He also has received travel support for an unpaid position on the Medical Advisory Board of the Tourette Syndrome Association. He is an unpaid member of the Scientific Advisory Board of the Trichotillomania Learning Center, the Scientific Council of the Anxiety and Depression Association of America, and a Scientific Advisor to the American Foundation of Suicide Prevention. Dr. Compton has received research support from NIMH and has served as a consultant to Shire Pharmaceuticals. He has received honoraria from the Nordic Long-Term Obsessive-Compulsive Disorder (OCD)-Treatment Study Research Group and Journal of Consulting and Clinical Psychology (JCCP). He has provided expert testimony at Duke Forensic Group. Dr. Sakolsky has received research support from NIMH and the National Alliance for Research on Schizophrenia and Depression (NARSAD). She has received honoraria from AACAP for teaching at the 2012 Annual Review Course. She has served as an editorial board member of Child and Adolescent Psychopharmacology News and is a specialty consultant for the Prescriber's Letter. Dr. Kendall has received grant support from NIMH and NICHD. He has received royalties from publication of the anxiety treatment materials and books on child mental health from Guilford Press, Ericsson, Workbook Publishing, and Oxford University Press. He has received honoraria from lectures on the topic of anxiety in youth. Dr. McCracken has received research support from NIMH, NICHD, Maternal and Child Health Bureau, Seaside Therapeutics, and Roche. He has served as a consultant to BioMarin and Roche. He has received speaker honoraria from the Tourette Syndrome Association Speaker’s Bureau, the Nevada Psychiatric Association, and AACAP. He has received study drug and placebo from Shire. Dr. Albano has received research grant support from NIMH, Duke University Research Institute, and private donors. She has received royalties from Oxford University Press, Lynn Sonberg Books, and Penguin/Avery Press. She has received honoraria from the American Psychological Association and consultant fees from Brackett Global. She is an unpaid member of the data safety monitoring board for IMPACT, a study via Cambridge University, UK. She is also an unpaid board of directors and scientific advisory board member of the Anxiety and Depression Association of America. Dr. Piacentini has received grant or research support from NIMH, Pfizer Pharmaceuticals through the Duke University Child and Adolescent Psychiatry Trials Network (CAPTN), and the Tourette Syndrome Association. He has served as a consultant to the Coleman Research Group and NIMH. He has served on the speakers’ bureau of the Tourette Syndrome Association and the International Obsessive Compulsive Disorder Foundation. He has received book royalties from Guilford Press and Oxford University Press. He is a coauthor of the Child OCD Impact Scale-Revised (COIS-R), the Child Anxiety Impact Scale (CAIS), the Parent Tic Questionnaire (PTQ), and the Premonitory Urge for Tics Scale (PUTS) assessment tools, all of which are in the public domain, and therefore no royalties are received. He has received financial support from the Furlotti Family Foundation to develop a computerized child OCD treatment program. Dr. Riddle has received grant or research funding from NIMH and drug from Bristol-Meyers Squibb. Dr. Keeton has received grant or research funding from NIMH and the Department of Education. Dr. Waslick has received research support from Pfizer (through the Duke University CAPTN), Sunovion, and Forest Laboratories. Dr. March has received research support from Pfizer, NIMH, and the National Institute on Drug Abuse (NIDA). He has served as a consultant or scientific advisor to Pfizer, Eli Lilly and Co., Bristol-Myers Squibb, and Attention Therapeutics. He has received study drug for an NIMH-funded study from Eli Lilly and Co. and Pfizer. He is an equity holder in MedAvante and has received royalties from Guilford Press, Oxford University Press, and MultiHealth Systems. Dr. Birmaher has received grant support from NIMH and book royalties from Random House, Inc., Lippincott Williams and Wilkins, and UpToDate. Drs. Sherrill, Shen, Chrisman, and Iyengar report no biomedical financial interests or potential conflicts of interest. |
Vol 54 - N° 3
P. 180-190 - mars 2015 Retour au numéro
Article précédent
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