Evidence map›Paper›PMID 31128268›Full record

Trial reportJournal of the American Academy of Child and Adolescent Psychiatry2020

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 and 11 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Academy of Child and Adolescent Psychiatry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00794040 (A Controlled Trial of Citalopram Added to Methylphenidate in Youth With Severe Mood Dysregulation), which is not on this map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
6.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00794040 phase2completednot on this map

A Controlled Trial of Citalopram Added to Methylphenidate in Youth With Severe Mood Dysregulation

TypeinterventionalSponsorNational Institute of Mental Health (NIMH)Ran2008 to 2018Enrolled103ConditionsMood Disorder, Mental Disorder Diagnosed in Childhood, Attention Deficit and Disruptive Behavior Disorder, Attention Deficit Hyperactivity DisorderArmsAdd-on citalopram following optimized methylphenidate, Add-on placebo following optimized methylphenidate
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Association between irritability and suicidal ideation in three clinical trials of adults with major depressive disorder.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2020
    Trial
  8. Trial
  9. An Exposure-Based Cognitive-Behavioral Therapy for Youth with Severe Irritability: Feasibility and Preliminary Efficacy.Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53
    Trial
  10. Review
  11. Article
  12. Article
  13. Article
  14. The Evolving ADHD Phenotype in the Externalizing Context.The American journal of psychiatry · 2026
    Review
  15. Review
  16. Article
  17. Irritability in Youths: A Critical Integrative Review.The American journal of psychiatry · 2024
    Review
  18. Article
  19. Article
  20. Review: Defining Positive Emotion Dysregulation: Integrating Temperamental and Clinical Perspectives.Journal of the American Academy of Child and Adolescent Psychiatry · 2023
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 7 institutions in 3 countries.

Kenneth TowbinMood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Pablo Vidal-RibasMood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD; Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
Melissa A BrotmanNeuroscience and Novel Therapeutics, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Andrew PicklesInstitute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
Katherine V MillerMood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Ariela KaiserMood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Aria D VitaleMood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Chana EngelMood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Gerald P OvermanNational Institutes of Health, Bethesda, MD.
Mollie DavisSection on Mood Dysregulation and Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Beth LeeCollege of Nursing, University of Arizona, Tuscon.
Cheri McNeilSection on Mood Dysregulation and Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Wanda WheelerSection on Mood Dysregulation and Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Catherine H YokumSection on Mood Dysregulation and Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Catherine T HaringUniversity of Michigan, Ann Arbor.
Alexandra RoulePenn State University, State College, PA.
Caroline G WambachGeorgetown University School of Medicine, Washington, DC.
Banafsheh Sharif-AskaryDuke University School of Medicine, Durham, NC.
Daniel S PineSection on Development and Affective Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Ellen LeibenluftSection on Mood Dysregulation and Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Argyris StringarisMood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD. Electronic address: argyris.stringaris@nih.gov.
National Institutes of Health · USDuke University · USGeorgetown University · USKing's College London · GBPennsylvania State University · USUniversity of Arizona · USUniversity of Michigan · US

Funding

The Pathophysiology and Treatment Of Children With Severe Mood DysregulationZIAMH002786 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI LEIBENLUFT, ELLEN · 2009 to 2023
$34.0M
Mood, Brain, and Development UnitZIAMH002957 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI STRINGARIS, ARGYRIOS · 2017 to 2022
$14.8M
Unit on Neuroscience and Novel TherapeuticsZIAMH002969 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI BROTMAN, MELISSA · 2019 to 2025
$13.8M
Department of HealthIntramural NIH HHS ZIA MH002786
6 · The paper itself

Abstract

objectiveDespite 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.

methodAfter 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.

resultsAt 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.

conclusionAdjunctive 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.

Indexed as

Central Nervous System StimulantsMethylphenidateAdolescentAttention Deficit and Disruptive Behavior DisordersCitalopramDouble-Blind MethodHumansIrritable MoodTreatment OutcomeCentral Nervous System StimulantsCitalopramMethylphenidatecitalopramdisruptive mood dysregulation disorderirritabilitymethylphenidateRCT

Identifiers

PMID31128268
PMCPMC9706653
OpenAlexW2945715054

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.