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

A Randomized, Double-blind, Placebo Controlled Study of the Efficacy of Adjunctive Lithium for the Treatment of Psychotic Mania Followed by an Open Label Long-term Safety Period.

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.

Inclusion Criteria:

• Males and females, 12-18 years old, inpatients or outpatients
• meet DSM-IV criteria for Bipolar I disorder - manic or mixed episode
• psychotic symptoms present

Exclusion criteria:

• current serious homicidal/suicidal ideation
• prior non-response or intolerance to an adequate trial of lithium
• prior non-response or intolerance to adequate trials of both aripiprazole and risperidone
• any unstable medical condition or medical contraindication to treatment with lithium, aripiprazole or risperidone
• inability or unwillingness to discontinue concomitant medication that interferes with the pharmacokinetics of either lithium, aripiprazole, or risperidone
• seizure disorder
• pregnant or, if sexually active, not using birth control, such as oral contraceptives, two barrier methods, long-acting depot preparations or an intra-uterine device
• Full Scale IQ less than 70
• meets criteria for a DSM-IV diagnosis of substance-induced mood disorder or mood disorder due to a general medical condition.