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

• Status: Withdrawn
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Collaborator: National Institutes of Health (NIH)
• Treatments: Antipsychotic Agents; Lithium Carbonate

Criteria

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.