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Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Suicidality

Intervention: paliperidone (Drug); lithium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Richard C Shelton, M.D., Principal Investigator, Affiliation: University of Alabama at Birmingham

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.

Clinical Details

Official title: Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Paliperidone and Lithium in the treatment of suicidality - treatment indication and epigenetic regulation

Secondary outcome: Paliperidone and Lithium in the treatment of suicidality - treatment indication and epigenetic regulation

Eligibility

Minimum age: 19 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. 19-65 years of age 2. Diagnosis of major depressive disorder 3. Currently experiencing suicidal thoughts Exclusion Criteria: 1. Depressed patients without suicidality 2. Patients with severe psychotic features or with primary diagnoses of bipolar disorder, schizoaffective disorder, schizophrenia, substance abuse/dependence or generalized anxiety 3. Subjects who have taken lithium or an antipsychotic in the last 2 weeks 4. pregnant women.

Locations and Contacts

UAB, Birmingham, Alabama 35294, United States
Additional Information

Starting date: May 2010
Last updated: March 17, 2014

Page last updated: August 23, 2015

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