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

This study has been completed.
Sponsor:
Collaborators:
American Foundation for Suicide Prevention
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01134731
First received: May 20, 2010
Last updated: March 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Suicidality
Drug: paliperidone
Drug: lithium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Paliperidone and Lithium in the treatment of suicidality - treatment indication and epigenetic regulation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The Beck Scale for Suicidal Ideation will be used to measure the efficacy of the study drugs.


Secondary Outcome Measures:
  • Paliperidone and Lithium in the treatment of suicidality - treatment indication and epigenetic regulation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The Montgomery-Asberg Depression Rating Scale will be used to measure depressive symptoms to determine the efficacy of the study drugs.


Enrollment: 41
Study Start Date: May 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paliperidone
3-6 mg qd
Drug: paliperidone
3-6 mg qd
Active Comparator: lithium
mood stabilizer
Drug: lithium
300-1500mg QD

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134731

Locations
United States, Alabama
UAB
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
American Foundation for Suicide Prevention
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Principal Investigator: Richard C Shelton, M.D. University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01134731     History of Changes
Other Study ID Numbers: F100329001
Study First Received: May 20, 2010
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
depression
suicidality
Diagnosis of Major Depressive Disorder currently experiencing a depressive episode with suicidality

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Lithium
9-hydroxy-risperidone
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014