Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation (AFSP)
This study is currently recruiting participants.
Verified March 2012 by University of Alabama at Birmingham
Sponsor:
University of Alabama at Birmingham
Collaborators:
American Foundation for Suicide Prevention
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Dr. Richard Shelton, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01134731
First received: May 20, 2010
Last updated: March 15, 2012
Last verified: March 2012
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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: placebo 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.
| Estimated Enrollment: | 69 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: paliperidone
3-6 mg qd
|
Drug: paliperidone
3-6 mg qd
|
|
Placebo Comparator: placebo
placebo
|
Drug: placebo
1 cap BID
|
|
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:
- 19-65 years of age
- Diagnosis of major depressive disorder
- Currently experiencing suicidal thoughts
Exclusion Criteria:
- Depressed patients without suicidality
- Patients with severe psychotic features or with primary diagnoses of bipolar disorder, schizoaffective disorder, schizophrenia, substance abuse/dependence or generalized anxiety
- Subjects who have taken lithium or an antipsychotic in the last 2 weeks
- pregnant women.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134731
Contacts
| Contact: Roberta S May, MA | 205-934-2605 | bmay@uab.edu |
| Contact: Hollis E Reeves, BS | 205-975-0068 | hreeves@uab.edu |
Locations
| United States, Alabama | |
| UAB | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Roberta S May, MA 205-934-2605 bmay@uab.edu | |
| Contact: Reeves E. Reeves, BS 205-975-0068 hreeves@uab.edu | |
| Principal Investigator: Richard C Shelton, MD | |
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: | Dr. Richard Shelton, Professor, 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 15, 2012 |
| 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 May 22, 2013