Status:
WITHDRAWN
Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
12-18 years
Phase:
PHASE4
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 wil...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01495156
Start Date
September 1 2011
End Date
September 1 2015
Last Update
January 22 2014
Active Locations (1)
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1
The Zucker Hillside Hospital, North Shore-LIJ Health System
Glen Oaks, New York, United States, 11004