drugset / Trial / NCT01134731
Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation
Phase 4
Completed
54 enrolled
University of Alabama at Birmingham
American Foundation for Suicide Prevention · collabOrtho-McNeil Janssen Scientific Affairs, LLC · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The study aims to use a combined clinical and translational approach to identify an efficient pharmacotherapy for the acute management of suicidality and the epigenetic regulation associated with the treatment.The primary objective is a clinical trial to compare the efficacy of paliperidone versus lithium and placebo as adjunctive therapy to the standard of care antidepressants in the acute management of suicidality in depressed subjects. Specific Aims 1 and 2 are described in detail below. Analysis for Specific Aim 2 is still underway.
Timeline
- Start
- 2010-05
- Primary completion
- 2014-02
- Completion
- 2014-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lithium | Unknown | 300 mg | — |
| Comparator | Lithium | Unknown | 600 mg | — |
| Comparator | Lithium | Unknown | 900 mg | — |
| Comparator | Lithium | Unknown | 1200 mg | — |
| Comparator | Lithium | Unknown | 1500 mg | — |
| Subject | Paliperidone | Unknown | 1 mg | — |
| Subject | Paliperidone | Unknown | 2 mg | — |
| Subject | Paliperidone | Unknown | 3 mg | — |
| Subject | Paliperidone | Unknown | 4 mg | — |
| Subject | Paliperidone | Unknown | 5 mg | — |