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Vilazodone for the Treatment of Posttraumatic Stress Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Vilazodone for the Treatment of Posttraumatic Stress Disorder

A Double-blind, Placebo-controlled Randomized Trial of Vilazodone in the Treatment of Posttraumatic Stress Disorder

NCT01715519•Southern California Institute for Research and Education

Summary

The purpose of this study is to determine whether vilazodone is effective in the treatmen of Posttraumatic Stress Disorder (PTSD)and co-morbid mild or more depression.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must satisfy DSM-IV diagnostic criteria for chronic PTSD
•Evidence of PTSD disease base upon one or more of the following:
•Mild or greater depression on the Beck Depression Inventory -II (BDI-II, score\> 12).
•May have other symptom co-morbid with PTSD (e.g., anxiety or somatic pain)
•Ability to comprehend and satisfactorily comply with protocol required and signed written informed consent prior to entering study procedure
•May be in psychotherapy if initiated at least three months prior to the screening visit. Subject must not discontinue or otherwise alter therapy during the study.
•Subject may not have taken any psychopharmacological medications within 7 days prior to Baseline visit.
•Negative urine pregnancy test at screening visit and for the duration of the study for women of childbearing potential.

Exclusion Criteria

•Patients with a concurrent DSM-IV Axis I diagnosis in any of the following categories:
•1. Delirium, Dementia, Amnestic and other Cognitive disorders
•2. Lifetime Schizophrenia and other Psychotic Disorders
•3. lifetime Bipolar I Disorder
•4. Bipolar-II Disorder with an episode of hypomania within the last year
•5. Alcohol or Substance Dependence or Abuse (excluding nicotine) in one month prior to the Screening Visit
•6. Any other concurrent Axis I Disorder (including Major Depressive Disorder) must be secondary to the primary diagnosis of PTSD.
•Decisional incapacity (dementia)
•Use of centrally acting medications that potentially have an effect on biological expression
•Chronic pain levels requiring use of any opiate medications
+15 more criteria

Locations (2)

Veterans Affairs Long Beach Healthcare System

Long Beach, California, United States

Veterans Affairs Nebraska Western-Iowa Healthcare Systems

Omaha, Nebraska, United States

Key Dates

Start Date

October 1, 2012

Primary Completion Date

December 1, 2015

Completion Date

December 1, 2015

Last Updated

April 25, 2017

Enrollment

ACTUAL participants

Conditions

PTSDDepression

Interventions

Treatment (Viibryd)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vilazodone for the Treatment of Posttraumatic Stress Disorder

Inclusion Criteria

Exclusion Criteria

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