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

Publication ,  Journal Article
Findling, RL; McNamara, NK; Pavuluri, M; Frazier, JA; Rynn, M; Scheffer, R; Kafantaris, V; Robb, A; DelBello, M; Kowatch, RA; Rowles, BM ...
Published in: J Am Acad Child Adolesc Psychiatry
February 2019

OBJECTIVE: This study examined the role of lithium in the maintenance treatment of pediatric patients with bipolar I disorder (BP-I). METHOD: Participants 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. RESULTS: A 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. CONCLUSION: This 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).

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Published In

J Am Acad Child Adolesc Psychiatry

DOI

EISSN

1527-5418

Publication Date

February 2019

Volume

58

Issue

2

Start / End Page

287 / 296.e4

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Psychiatric Status Rating Scales
  • Proportional Hazards Models
  • Patient Dropouts
  • Male
  • Lithium Compounds
  • Humans
  • Female
  • Double-Blind Method
 

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Findling, R. L., McNamara, N. K., Pavuluri, M., Frazier, J. A., Rynn, M., Scheffer, R., … Taylor-Zapata, P. (2019). Lithium for the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Discontinuation Study. J Am Acad Child Adolesc Psychiatry, 58(2), 287-296.e4. https://doi.org/10.1016/j.jaac.2018.07.901
Findling, Robert L., Nora K. McNamara, Mani Pavuluri, Jean A. Frazier, Moira Rynn, Russell Scheffer, Vivian Kafantaris, et al. “Lithium for the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Discontinuation Study.J Am Acad Child Adolesc Psychiatry 58, no. 2 (February 2019): 287-296.e4. https://doi.org/10.1016/j.jaac.2018.07.901.
Findling RL, McNamara NK, Pavuluri M, Frazier JA, Rynn M, Scheffer R, et al. Lithium for the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Discontinuation Study. J Am Acad Child Adolesc Psychiatry. 2019 Feb;58(2):287-296.e4.
Findling, Robert L., et al. “Lithium for the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Discontinuation Study.J Am Acad Child Adolesc Psychiatry, vol. 58, no. 2, Feb. 2019, pp. 287-296.e4. Pubmed, doi:10.1016/j.jaac.2018.07.901.
Findling RL, McNamara NK, Pavuluri M, Frazier JA, Rynn M, Scheffer R, Kafantaris V, Robb A, DelBello M, Kowatch RA, Rowles BM, Lingler J, Zhao J, Clemons T, Martz K, Anand R, Taylor-Zapata P. Lithium for the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Discontinuation Study. J Am Acad Child Adolesc Psychiatry. 2019 Feb;58(2):287-296.e4.
Journal cover image

Published In

J Am Acad Child Adolesc Psychiatry

DOI

EISSN

1527-5418

Publication Date

February 2019

Volume

58

Issue

2

Start / End Page

287 / 296.e4

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Psychiatric Status Rating Scales
  • Proportional Hazards Models
  • Patient Dropouts
  • Male
  • Lithium Compounds
  • Humans
  • Female
  • Double-Blind Method