title: Lithium in the Acute Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Study.
abstract: BACKGROUND
  Lithium is a benchmark treatment for bipolar disorder in adults. Definitive studies of lithium in pediatric bipolar I disorder (BP-I) are lacking.
  
  
  METHODS
  This 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  Lithium 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.
authors.affiliation: The Johns Hopkins University/Kennedy Krieger Institute, Baltimore, Maryland; rfindli1@jhmi.edu.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
authors.affiliation: Children's National Medical Center, George Washington University, Washington District of Columbia;
authors.forename: Adelaide
authors.initials: A
authors.lastname: Robb
authors.affiliation: Department of Psychiatry, Case Western Reserve University, Cleveland, Ohio;
authors.forename: Nora K
authors.initials: NK
authors.lastname: McNamara
authors.affiliation: Department of Psychiatry, University of Illinois at Chicago, Chicago, Illinois;
authors.forename: Mani N
authors.initials: MN
authors.lastname: Pavuluri
authors.affiliation: The Zucker Hillside Hospital and Feinstein Institute for Medical Research of the North Shore-Long Island Jewish Health System, Manhasset, New York;
authors.forename: Vivian
authors.initials: V
authors.lastname: Kafantaris
authors.affiliation: University of Kansas School of Medicine, Wichita, Kansas;
authors.forename: Russell
authors.initials: R
authors.lastname: Scheffer
authors.affiliation: Department of Psychiatry, University of Massachusetts Medical School/UMASS Memorial Medical Center, Worcester, Massachusetts;
authors.forename: Jean A
authors.initials: JA
authors.lastname: Frazier
authors.affiliation: New York State Psychiatric Institute/Columbia University, New York, New York;
authors.forename: Moira
authors.initials: M
authors.lastname: Rynn
authors.affiliation: University of Cincinnati College of Medicine, Cincinnati, Ohio;
authors.forename: Melissa
authors.initials: M
authors.lastname: DelBello
authors.affiliation: Wexner Medical Center/Nationwide Children's Hospital, The Ohio State University, Columbus, Ohio;
authors.forename: Robert A
authors.initials: RA
authors.lastname: Kowatch
authors.affiliation: UPMC CancerCenter, Pittsburgh, Pennsylvania;
authors.forename: Brieana M
authors.initials: BM
authors.lastname: Rowles
authors.affiliation: Department of Psychiatry, Case Western Reserve University, Cleveland, Ohio;
authors.forename: Jacqui
authors.initials: J
authors.lastname: Lingler
authors.affiliation: The EMMES Corporation, Rockville, Maryland; and.
authors.forename: Karen
authors.initials: K
authors.lastname: Martz
authors.affiliation: The EMMES Corporation, Rockville, Maryland; and.
authors.forename: Ravinder
authors.initials: R
authors.lastname: Anand
authors.affiliation: The EMMES Corporation, Rockville, Maryland; and.
authors.forename: Traci E
authors.initials: TE
authors.lastname: Clemons
authors.affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
authors.forename: Perdita
authors.initials: P
authors.lastname: Taylor-Zapata
mesh_terms: D000293:Adolescent; D018692:Antimanic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000145:classification / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D018020:Lithium Compounds / Q000627:therapeutic use*; D008297:Male
chemical_list: D018692:Antimanic Agents; D018020:Lithium Compounds