Table 7-2, COLT1 Participant Disposition Plus Last Measured Lithium Concentration and Dose - 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)

Participant Disposition	Number	Weeks of Rx (mean)	Concentration mEq/L (mean)	Total Daily Dose in mg (mean)
Completed	46	8.16	1.06 Range (0.41-2.08)	1495 Range (900-2400)
Terminated	11
AEs	2	4.05	0.82	1350
Consent/assent withdrawn	3	3.10	1.14	1500
Lack of efficacy	2	2.50	0.57	1200
Protocol noncompliance	2	3.00	0.72	1500
Other Early Termination (ET) Reason	2	4.45	1.15	1650

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].

Findling R, Taylor-Zapata P, Anand R, et al.; Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Bethesda (MD): National Institute of Child Health and Human Development (US); 2015 Dec 1.

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Table 7-2COLT1 Participant Disposition Plus Last Measured Lithium Concentration and Dose