drugset / Trial / NCT01495156

Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania

NCT01495156

RandomizedParallel-groupTriple-blindTreatment

Summary

The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial comparing two treatment strategies in adolescents with mania and prominent psychotic features. One group will receive a second generation antipsychotic (SGA) and placebo and the other will receive a SGA and lithium. The primary double-blind phase of the study will last 8 weeks, followed by a 24-week extension-phase.

Timeline

Start
2011-09
Primary completion
2014-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Lithium Unknown 1200 mg
Background Aripiprazole Other / unclassified 10 mg
Background Risperidone Other / unclassified 2.5 mg

Indications