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

Condition(s) targeted: Bipolar I Disorder

Intervention: Lithium treatment in combination with a SGA (Second Generation Antipsychotic) (Drug); Placebo/Adjunctive SGA treatment (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: North Shore Long Island Jewish Health System

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.

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Acute phase :Time to partial or full response

Continuation Phase: time to recurrence of a subsyndromal mood episode

Secondary outcome:

Acute phase: number of suicidal events

Acute phase: positive urine toxicology screens (yes/no variable)

Acute phase: adherence to medication regimen.

Minimum age: 12 Years. Maximum age: 18 Years. Gender(s): Both.

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.

The Zucker Hillside Hospital, North Shore-LIJ Health System, Glen Oaks, New York 11004, United States

Starting date: September 2011
Last updated: January 21, 2014