Evidence map›Paper›PMID 26459650›Full record

Trial reportPediatrics2015

Lithium in the Acute Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Study.

Robert L Findling, Adelaide Robb, Nora K McNamara, Mani N Pavuluri, Vivian Kafantaris, Russell Scheffer, Jean A Frazier, Moira Rynn, Melissa DelBello, Robert A Kowatch and 6 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatrics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 6 pooled it
11.4field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 6 syntheses or guidelines pooled it, 157 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Lithium for acute mania.The Cochrane database of systematic reviews · 2019
    Pooled it
  5. Pooled it
  6. Guideline
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Article
  13. Review
  14. Creativity in Pediatric Clinical Pharmacology: Study Design and Oral Dosage Forms.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024
    Article
  15. Review
  16. Review
  17. Article
  18. What Patients with Bipolar Disorder Need to Know about Lithium.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  19. Review
  20. Article
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

16 authors at 13 institutions in 1 country.

Robert L FindlingThe Johns Hopkins University/Kennedy Krieger Institute, Baltimore, Maryland; rfindli1@jhmi.edu.
Adelaide RobbChildren's National Medical Center, George Washington University, Washington District of Columbia;
Nora K McNamaraDepartment of Psychiatry, Case Western Reserve University, Cleveland, Ohio;
Mani N PavuluriDepartment of Psychiatry, University of Illinois at Chicago, Chicago, Illinois;
Vivian KafantarisThe Zucker Hillside Hospital and Feinstein Institute for Medical Research of the North Shore-Long Island Jewish Health System, Manhasset, New York;
Russell SchefferUniversity of Kansas School of Medicine, Wichita, Kansas;
Jean A FrazierDepartment of Psychiatry, University of Massachusetts Medical School/UMASS Memorial Medical Center, Worcester, Massachusetts;
Moira RynnNew York State Psychiatric Institute/Columbia University, New York, New York;
Melissa DelBelloUniversity of Cincinnati College of Medicine, Cincinnati, Ohio;
Robert A KowatchWexner Medical Center/Nationwide Children's Hospital, The Ohio State University, Columbus, Ohio;
Brieana M RowlesUPMC CancerCenter, Pittsburgh, Pennsylvania;
Jacqui LinglerDepartment of Psychiatry, Case Western Reserve University, Cleveland, Ohio;
Karen MartzThe EMMES Corporation, Rockville, Maryland; and.
Ravinder AnandThe EMMES Corporation, Rockville, Maryland; and.
Traci E ClemonsThe EMMES Corporation, Rockville, Maryland; and.
Perdita Taylor-ZapataEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Emmes (United States) · USCase Western Reserve University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USGeorge Washington University · USJohns Hopkins University · USNationwide Children's Hospital · USNew York Psychoanalytic Society and Institute · USUMass Memorial Medical Center · USUniversity of Cincinnati Medical Center · USUniversity of Illinois Chicago · USUniversity of Kansas · USUniversity of Pittsburgh Medical Center · USZucker Hillside Hospital · US

Funding

LCenter for Clinical and Translational Science and TrainingUL1TR001425 · NCATS · UNIVERSITY OF CINCINNATI · PI MEINZEN-DERR, JAREEN, STRAWN, JEFFREY ROBERT · 2015 to 2024
$37.5M
NCATS NIH HHS UL1 TR001425PHS HHS HHSN275200503406C
6 · The paper itself

Abstract

backgroundLithium is a benchmark treatment for bipolar disorder in adults. Definitive studies of lithium in pediatric bipolar I disorder (BP-I) are lacking.

methodsThis multicenter, randomized, double-blind, placebo-controlled study of pediatric participants (ages 7-17 years) with BP-I/manic or mixed episodes compared lithium (n = 53) versus placebo (n = 28) for up to 8 weeks. The a priori primary efficacy measure was change from baseline to the end of study (week 8/ET) in the Young Mania Rating Scale (YMRS) score, based on last-observation-carried-forward analysis.

resultsThe change in YMRS score was significantly larger in lithium-treated participants (5.51 [95% confidence interval: 0.51 to 10.50]) after adjustment for baseline YMRS score, age group, weight group, gender, and study site (P = .03). Overall Clinical Global Impression-Improvement scores favored lithium (n = 25; 47% very much/much improved) compared with placebo (n = 6; 21% very much/much improved) at week 8/ET (P = .03). A statistically significant increase in thyrotropin concentration was seen with lithium (3.0 ± 3.1 mIU/L) compared with placebo (-0.1 ± 0.9 mIU/L; P < .001). There was no statistically significant between-group difference with respect to weight gain.

conclusionsLithium was superior to placebo in reducing manic symptoms in pediatric patients treated for BP-I in this clinical trial. Lithium was generally well tolerated in this patient population and was not associated with weight gain, distinguishing it from other agents commonly used to treat youth with bipolar disorder.

Indexed as

AdolescentAntimanic AgentsBipolar DisorderChildDouble-Blind MethodFemaleHumansLithium CompoundsMaleAntimanic AgentsLithium Compounds

Identifiers

PMID26459650
PMCPMC4621794
OpenAlexW2192730836

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.