Dataset Information

A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability.

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://clinicaltrials.gov; NCT00794040.

SUBMITTER: Towbin K

PROVIDER: S-EPMC9706653 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Publications

A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability.

Towbin Kenneth K Vidal-Ribas Pablo P Brotman Melissa A MA Pickles Andrew A Miller Katherine V KV Kaiser Ariela A Vitale Aria D AD Engel Chana C Overman Gerald P GP Davis Mollie M Lee Beth B McNeil Cheri C Wheeler Wanda W Yokum Catherine H CH Haring Catherine T CT Roule Alexandra A Wambach Caroline G CG Sharif-Askary Banafsheh B Pine Daniel S DS Leibenluft Ellen E Stringaris Argyris A

Journal of the American Academy of Child and Adolescent Psychiatry 20190523 3

<h4>Objective</h4>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.<h4>Method</h4>After a lead-in phase of open treatment with stimulant, 53 youth meeting criteria for severe mood dysregulation (SMD) were rando ...[more]

PMID: 31128268

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Dataset Information

A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability.

Objective

Method

Results

Conclusion

Clinical trial registration information

Publications

A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability.

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