A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability - 20/02/20
Abstract |
Objective |
Despite the clinical importance of chronic and severe irritability, there is a paucity of controlled trials for its pharmacological treatment. Here, we examine the effects of adding citalopram (CTP) to methylphenidate (MPH) in the treatment of chronic severe irritability in youth using a double-blind randomized placebo-controlled design.
Method |
After a lead-in phase of open treatment with stimulant, 53 youth meeting criteria for severe mood dysregulation (SMD) were randomly assigned to receive CTP or placebo (PBO) for 8 weeks. A total of 49 participants, 48 of them (98%) meeting disruptive mood dysregulation disorder (DMDD) criteria, were included in the intent-to-treat analysis. The primary outcome measure was the proportion of response based on improvements of irritability at the week 8 of the trial.
Results |
At the end of the trial, a significantly higher proportion of response was seen in those participants randomly assigned to CTP+MPH compared to PBO+MPH (35% CTP+MPH versus 6% PBO+MPH; odds ratio = 11.70, 95% CI = 2.00−68.16, p = 0.006). However, there were no differences in functional impairment between groups at the end of the trial. No differences were found in any adverse effect between treatment groups, and no trial participant exhibited hypomanic or manic symptoms.
Conclusion |
Adjunctive CTP might be efficacious in the treatment of chronic severe irritability in youth resistant to stimulant treatment alone.
Clinical trial registration information |
A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation; clinicaltrials.gov; NCT00794040.
Le texte complet de cet article est disponible en PDF.Key words : irritability, disruptive mood dysregulation disorder, citalopram, methylphenidate, RCT
Plan
| Drs. Towbin and Vidal-Ribas contributed equally to this research. |
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| This study represents independent research funded by Intramural Research Program (ZIAMH002786) of the National Institute of Mental Health (NIMH) with analysis supported by the UKNational Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London. The views expressed are those of the author(s) and not necessarily those of the UK NHS, NIHR, or the Department of Health and Social Care of United Kingdom. |
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| Drs. Vidal-Ribas and Pickles served as the statistical experts for this research. |
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| The authors wish to acknowledge the skill, dedication, and effort of the 1 SW Nursing Staff from the NIH Clinical Center, Bethesda, MD, without whom this study would not have been possible. They gratefully acknowledge the children and families who participated in this trial and made this research possible. |
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| Disclosure: Drs. Towbin, Vidal-Ribas, Brotman, Pickles, Overman, McNeil, Haring, Pine, Leibenluft, and Stringaris and Mss. Miller, Kaiser, Vitale, Engel, Davis, Lee, Wheeler, Yokum, Roule, Wambach, and Sharif-Askary have reported no biomedical financial interests or potential conflicts of interest. |
Vol 59 - N° 3
P. 350-361 - mars 2020 Retour au numéro
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