Trial reportJournal of child and adolescent psychopharmacology2009
Randomized double-blind placebo-controlled trial of lithium in youths with severe mood dysregulation.
Trial report in Journal of child and adolescent psychopharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01844700 (1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain), which is not on this map. Cited by 55 papers, 6 of them syntheses that pooled 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.
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.
1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain
Who cites it
55 citing papers in PubMed, 6 syntheses or guidelines pooled it, 147 citations in OpenAlex.
- Treatment of Early-Onset Specified and Unspecified Bipolar Disorders: A Systematic Review and Strategies for Identifying and Managing a Thermally Dysregulated Subtype in Children.Acta psychiatrica Scandinavica · 2025Pooled it
- Psychopharmacological treatment of disruptive behavior in youths: systematic review and network meta-analysis.Scientific reports · 2023Pooled it
- Putative Mechanisms of Action and Clinical Use of Lithium in Children and Adolescents: A Critical Review.Current neuropharmacology · 2019Pooled it
- Evidence-based treatments for youths with severely dysregulated mood: a qualitative systematic review of trials for SMD and DMDD.European child & adolescent psychiatry · 2017Pooled it
- The Status of Irritability in Psychiatry: A Conceptual and Quantitative Review.Journal of the American Academy of Child and Adolescent Psychiatry · 2016Pooled it
- Smaller hippocampal volumes in patients with bipolar disorder are masked by exposure to lithium: a meta-analysis.Journal of psychiatry & neuroscience : JPN · 2012Pooled it
- A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability.Journal of the American Academy of Child and Adolescent Psychiatry · 2020Trial
- Interpersonal psychotherapy for mood and behavior dysregulation: Pilot randomized trial.Depression and anxiety · 2018Trial
- A Randomized Clinical Trial of an Integrative Group Therapy for Children With Severe Mood Dysregulation.Journal of the American Academy of Child and Adolescent Psychiatry · 2016Trial
- The Effectiveness and Tolerability of Central Nervous System Stimulants in School-Age Children with Attention-Deficit/Hyperactivity Disorder and Disruptive Mood Dysregulation Disorder Across Home and School.Journal of child and adolescent psychopharmacology · 2016Trial
- A novel group therapy for children with ADHD and severe mood dysregulation.Journal of attention disorders · 2013Trial
- Trial
- 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 53Trial
- Treatment of disruptive mood dysregulation disorder with autism spectrum disorder and attention-deficit/hyperactivity disorder.The mental health clinician · 2026Article
- Efficacy and Safety of Lithium for Suicide and Suicide-Related Behaviors in Youth: A Review of the Literature.Brain sciences · 2024Review
- Extended-Release Lithium Treatment for Adolescents with Bipolar Disorder with or Without Comorbid Autism Spectrum Disorder: Protocol of a Longitudinal Prospective Naturalistic Study for the Assessment of Efficacy and Tolerability.Journal of clinical medicine · 2024Article
- Can peripheral psychophysiological markers predict response to exposure-based cognitive behavioral therapy in youth with severely impairing irritability? A study protocol.BMC psychiatry · 2023Article
- Review
- A Delphi consensus among experts on assessment and treatment of disruptive mood dysregulation disorder.Frontiers in psychiatry · 2023Article
- Frustration, Cognition, and Psychophysiology in Dysregulated Children: A Research Domain Criteria Approach.Journal of the American Academy of Child and Adolescent Psychiatry · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
Abstract
objectiveThe diagnosis and treatment of youth with severe nonepisodic irritability and hyperarousal, a syndrome defined as severe mood dysregulation (SMD) by Leibenluft, has been the focus of increasing concern. We conducted the first randomized double-blind, placebo-controlled trial in SMD youth, choosing lithium on the basis of its potential in treating irritability and aggression and neuro-metabolic effects.
methodsSMD youths 7-17 years were tapered off their medications. Those who continued to meet SMD criteria after a 2-week, single-blind, placebo run-in were randomized to a 6-week double-blind trial of either lithium (n = 14) or placebo (n = 11). Clinical outcome measures were: (1) Clinical Global Impressions-Improvement (CGI-I) score less than 4 at trial's end and (2) the Positive and Negative Syndrome Scale (PANSS) factor 4 score. Magnetic resonance spectroscopy (MRS) outcome measures were myoinositol (mI), N-acetyl-aspartate (NAA), and combined glutamate/glutamine (GLX), all referenced to creatine (Cr).
resultsIn all, 45% (n = 20/45) of SMD youths were not randomized due to significant clinical improvement during the placebo run-in. Among randomized patients, there were no significant between-group differences in either clinical or MRS outcome measures.
conclusionOur study suggests that although lithium may not result in significant clinical or neurometabolic alterations in SMD youths, further SMD treatment trials are warranted given its prevalence.
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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.