Evidence map›Paper›PMID 30738555›Full record

Trial reportJournal of the American Academy of Child and Adolescent Psychiatry2019

Lithium for the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Discontinuation Study.

Robert L Findling, Nora K McNamara, Mani Pavuluri, Jean A Frazier, Moira Rynn, Russell Scheffer, Vivian Kafantaris, Adelaide Robb, Melissa DelBello, Robert A Kowatch and 7 more

2 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Academy of Child and Adolescent Psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT00442039 phase2completednot on this map

Pediatric Pharmacokinetic and Tolerability Study of Lithium for the Treatment of Pediatric Mania Followed by an Open Label Long Term Safety Period, Discontinuation Phase, and Restabilization Period.

TypeinterventionalSponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Ran2006 to 2009Enrolled61ConditionsBipolar I Disorder Without Psychotic SymptomsArmsLithium Carbonate, Placebo
NCT01166425 phase2 / phase3completednot on this map

A Randomized, Double-blind, Placebo Controlled Study of the Efficacy of Lithium for the Treatment of Pediatric Mania Followed by an Open Label Long-term Safety Period, Double-blind, Placebo-controlled Discontinuation Phase, and Open Label Restabilization Period.

TypeinterventionalSponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Ran2010 to 2013Enrolled81ConditionsBipolar DisorderArmsLithium Carbonate, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Review
  7. The Challenges of Children with Bipolar Disorder.Medicina (Kaunas, Lithuania) · 2021
    Review
  8. Review
  9. Article
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 11 institutions in 2 countries.

Robert L FindlingThe Johns Hopkins University, Baltimore, MD. Electronic address: RFindli1@jhmi.edu.
Nora K McNamaraCase Western Reserve University, Cleveland, OH.
Mani PavuluriThe Brain and Wellness Institute, Chicago, IL.
Jean A FrazierUniversity of Massachusetts Medical School, Boston.
Moira RynnDuke University, Durham, NC.
Russell Schefferprivate practice.
Vivian KafantarisThe Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY.
Adelaide RobbGeorge Washington University School of Medicine & Health Sciences, Washington, DC.
Melissa DelBelloUniversity of Cincinnati College of Medicine, Cincinnati, OH.
Robert A KowatchOhio State University Wexner Medical Center, Columbus, OH.
Brieana M RowlesThe Johns Hopkins University, Baltimore, MD.
Jacqui LinglerThe EMMES Corporation, Rockville, MD.
Jian ZhaoThe EMMES Corporation, Rockville, MD.
Traci ClemonsThe EMMES Corporation, Rockville, MD.
Karen MartzThe EMMES Corporation, Rockville, MD.
Ravinder AnandThe EMMES Corporation, Rockville, MD.
Perdita Taylor-ZapataEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.
Emmes (United States) · USJohns Hopkins University · USCase Western Reserve University · USDonald & Barbara Zucker School of Medicine at Hofstra/Northwell · USDuke University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USGeorge Washington University · USIS practice · BEThe Ohio State University Wexner Medical Center · USUniversity of Cincinnati Medical Center · USUniversity of Massachusetts Chan Medical School · US

Funding

NICHD NIH HHS N01 HD053406
6 · The paper itself

Abstract

objectiveThis study examined the role of lithium in the maintenance treatment of pediatric patients with bipolar I disorder (BP-I).

methodParticipants aged 7 to 17 years who presented with a manic or mixed episode received 24 weeks of lithium treatment in one of two multiphase studies, the Collaborative Lithium Trials (CoLT 1 and CoLT 2). Responders were randomized to continue lithium or to be cross-titrated to placebo for up to 28 weeks. The primary outcome measure was relative risk of study discontinuation for any reason.

resultsA Cox regression analysis found that those who continued treatment with lithium (n = 17) had a lower hazard ratio compared to those who received placebo (n = 14) (p = .015)]. The vast majority of discontinuations were due to mood symptom exacerbations, with most of these occurring in the placebo-treated group. Discontinuation for other reasons occurred at similarly low rates across both group. Most adverse events were mild to moderate in severity, and only one study participant was discontinued from the trial owing to a serious adverse event (aggression). There was no statistically significant difference with respect to weight gain in participants receiving lithium compared to those receiving placebo.

conclusionThis randomized, double-blind, placebo-controlled Discontinuation Trial builds support for the role of lithium as a maintenance treatment in pediatric patients with bipolar disorder and for the safety and tolerability of 28 weeks of maintenance lithium treatment. CLINICAL TRIAL REGISTRATION INFORMATION: Lithium for the Treatment of Pediatric Mania; https://clinicaltrials.gov/; NCT00442039 (CoLT 1). Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania; https://clinicaltrials.gov/; NCT01166425 (CoLT 2).

Indexed as

Patient DropoutsAdolescentAntipsychotic AgentsBipolar DisorderChildDouble-Blind MethodFemaleHumansLithium CompoundsMaleProportional Hazards ModelsPsychiatric Status Rating ScalesTreatment OutcomeUnited StatesAntipsychotic AgentsLithium Compoundsbipolarchildrenlithiumtreatment

Identifiers

PMID30738555
PMCPMC6414078
OpenAlexW2902885865

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.