Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania.
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
Study Design This is the second study of a multiphase, multicenter trial that will
comprehensively examine lithium in the treatment of pediatric participants with bipolar I
disorder. In order to examine the treatment of bipolar disorder with lithium, this study will
include four phases of treatment. The first phase, the Efficacy Phase, will include
participants being randomized to either lithium or placebo for 8 weeks to determine the
efficacy of lithium in the treatment of children and adolescents with bipolar I disorder.
Once participants complete the Efficacy Phase, participants may be eligible to continue in
the Long- Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment.
Subsequently, participants meeting response criteria during the Long-Term Effectiveness Phase
will be eligible to continue in the Discontinuation Phase. During the Discontinuation Phase,
participants will be randomized to either placebo or lithium treatment for up to 28 weeks.
Finally, those participants who experience a mood relapse during the Discontinuation Phase
will be enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8
weeks.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)