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

Northwell Health

Status and phase

Withdrawn

Phase 4

Conditions

Bipolar I Disorder

Treatments

Drug: Lithium treatment in combination with a SGA (Second Generation Antipsychotic)

Drug: Placebo/Adjunctive SGA treatment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01495156

11-185

Details and patient eligibility

About

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.

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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.