A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability
Kenneth Towbin, Pablo Vidal-Ribas, Melissa A Brotman, Andrew Pickles, Katherine V Miller, Ariela Kaiser, Aria D Vitale, Chana Engel, Gerald P Overman, Mollie Davis, Beth Lee, Cheri McNeil, Wanda Wheeler, Catherine H Yokum, Catherine T Haring, Alexandra Roule, Caroline G Wambach, Banafsheh Sharif-Askary, Daniel S Pine, Ellen Leibenluft, Argyris Stringaris, Kenneth Towbin, Pablo Vidal-Ribas, Melissa A Brotman, Andrew Pickles, Katherine V Miller, Ariela Kaiser, Aria D Vitale, Chana Engel, Gerald P Overman, Mollie Davis, Beth Lee, Cheri McNeil, Wanda Wheeler, Catherine H Yokum, Catherine T Haring, Alexandra Roule, Caroline G Wambach, Banafsheh Sharif-Askary, Daniel S Pine, Ellen Leibenluft, Argyris Stringaris
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; https://ichgcp.net/clinical-trials-registry/NCT00794040" title="See in ClinicalTrials.gov">NCT00794040.
Keywords: RCT; citalopram; disruptive mood dysregulation disorder; irritability; methylphenidate.
Conflict of interest statement
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.
Published by Elsevier Inc.
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Source: PubMed