Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 12 - 18 |
| Updated: | 3/30/2013 |
| Start Date: | September 2011 |
| End Date: | September 2015 |
| Contact: | Linda Spritzer, BA |
| Email: | LSpritze@nshs.edu |
| Phone: | 516-562-3643 |
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.
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.
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.
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