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 (CoLT)

Protocol ID
10-046B

Protocol Description
This research study will examine the study drug, lithium, in the treatment of children and adolescents with Bipolar I disorder.

Eligibility Criteria
Eligible subjects are: a) outpatients b) 7-17 years old and c) currently experiencing a manic or mixed episode. Wash-out of current (ineffective) medications, if any,  is necessary for study participation.

Primary Investigator(s)
Vivian Kafantaris, MD

Contact Information
Vivian Kafantaris, MD: (718) 470 8556, vkafanta@lij.edu
Alison Berest, MA: (718) 470 8362, aberest@lij.edu