Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
Withdrawn before enrolling · Phase 4 · Has a placebo group
Conditions studied: Bipolar I Disorder
In brief
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.
Key facts
- Study ID
- NCT01495156
- Run by
- Northwell Health
- People needed
- 0
- Starts
- 2011-09-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2014-01-22
Who can join
Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The Zucker Hillside Hospital, North Shore-LIJ Health System — Glen Oaks, New York, United States
Full record on ClinicalTrials.gov
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