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Findling R, Taylor-Zapata P, Anand R, et al.; Eunice Kennedy Shriver National Institute of Child Health and Human Development. 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 (COLT2) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development (US); 2015 Dec 1.

Cover of 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 (COLT2)

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 (COLT2) [Internet].

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8STUDY OBJECTIVES

The purpose of this study was to investigate the use of lithium for the treatment of pediatric participants with mania.

8.1. Primary Study Objectives

The primary objectives of this study were:

  1. To determine if lithium is more efficacious in reducing symptoms of mania in the pediatric population than placebo.
  2. To describe the short-term safety of lithium in the pediatric population relative to placebo treatment.
  3. To examine the effectiveness and efficacy of lithium as a maintenance treatment for children and adolescents with bipolar I disorder.
  4. To examine the long-term and short-term safety and tolerability of lithium in pediatric bipolar disorder.

8.2. Secondary Objectives

The secondary objectives of this study were:

  1. To examine the effects of lithium treatment over time in the pediatric population on specific aspects of cognitive functioning that have been reported to be adversely affected by lithium in the adult population.
  2. To examine the relationship between the systemic exposure to lithium and effectiveness and toxicity in the pediatric population.
  3. To examine the long-term safety and tolerability of combination therapy (lithium plus other psychotropic agents) in pediatric bipolar disorder.
  4. To critically assess the efficacy of lithium for prophylaxis against recurrence of mood symptoms in children and adolescents.
  5. In those participants who discontinue treatment with lithium and experience a mood relapse, to determine the duration of lithium treatment necessary before re-stabilization is achieved.
  6. To evaluate the influence of intrinsic factors [e.g., age, gender, race, renal function, height, and weight] on lithium exposure in the pediatric population.

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