drugset / Trial / NCT01495156
Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2011-09
- Primary completion
- 2014-09
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lithium | Unknown | 1200 mg | — |
| Background | Aripiprazole | Other / unclassified | 10 mg | — |
| Background | Risperidone | Other / unclassified | 2.5 mg | — |