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

Phase 4

Withdrawn

• Conditions: Bipolar I Disorder
• Interventions: Drug: Lithium treatment in combination with a SGA (Second Generation Antipsychotic); Drug: Placebo/Adjunctive SGA treatment

• Registration Number: NCT01495156
• Lead Sponsor: Northwell Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-19
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-01-22
• Primary Completion: 2014-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lithium/Adjunctive SGA	Lithium treatment in combination with a SGA (Second Generation Antipsychotic)	-
Placebo/Adjunctive SGA	Placebo/Adjunctive SGA treatment	-

Primary Outcome Measures

Name	Time	Method
Acute phase :Time to partial or full response	8 weeks	Acute phase: Partial response is defined as at least a 25% -49% reduction in YMRS score and a CGI improvement item score of 2. Full response is defined as a reduction in YMRS score of 50% or more and a CGI improvement item score of 1 "very much improved."
Continuation Phase: time to recurrence of a subsyndromal mood episode	24 weeks	We will measure the amount of time for patients to have a recurrance of a subsyndomal mood episode during the Continuation Phase

Secondary Outcome Measures

Name	Time	Method
Acute phase: adherence to medication regimen.	8 weeks
Acute phase: number of suicidal events	8 weeks
Acute phase: positive urine toxicology screens (yes/no variable)	8 weeks

Trial Locations

Locations (1)

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