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Vilazodone for the Treatment of Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Michael Hollifield, MD, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT01715519
First received: October 18, 2012
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
PTSD Depression Drug: Treatment (Viibryd) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Randomized Trial of Vilazodone in the Treatment of Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Michael Hollifield, MD, Southern California Institute for Research and Education:

Primary Outcome Measures:
  • PTSD symptoms [ Time Frame: four months ]
    PCL-C

  • PTSD Diagnosis [ Time Frame: 4 months ]
    CAPS


Secondary Outcome Measures:
  • Depression [ Time Frame: four months ]
    BDI-II

  • Sleep [ Time Frame: 4 months ]
    PSQI

  • Anxiety [ Time Frame: 4 months ]
    HSCL-25


Other Outcome Measures:
  • Biomarkers [ Time Frame: four months ]
    serum


Enrollment: 59
Study Start Date: October 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (Viibryd)
10 mg/day 1 to 7; 20 mg/day 8 to 14; 40 mg/day week 3 to end week 12. Subjects will then be tapered off vilazodone as follows: 20 mg/day week 13, 10 mg/day, week 14 and no medication during week 15.
Drug: Treatment (Viibryd)
Other Name: Vilazodone
Placebo Comparator: Placebo
will be compared to the treatment group (viibryd)
Drug: Treatment (Viibryd)
Other Name: Vilazodone

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Known exposure to chemicals of physical traumas that cause neuropsychiatric sequelae
  • Past chronic PTSD
  • History of 2 or more treatment failures on SSRIs given primarily for the treatment of PTSD, in adequate does at the Investigator's opinion, for at least 8 weeks
  • History of intolerance or hypersensitivity to SSRI's
  • History of seizures
  • Significant risk of committing suicide, or are homicidal or violent and in the Investigator's opinion in significant imminent risk of hurting others
  • Treated with depot-neuroleptic within 3 months or MAO inhibitors within 30 day prior to Baseline visit
  • Received ECT within 3 months prior to Screening visit
  • Pregnant or nursing, women of childbearing potential who are sexually active and do not use adequate contraception, or who are judged to be unreliable in their use of contraception
  • Positive urine drug screen, unless proven to be prescribed for a short-term course of treatment. Drug screen must be repeated at least 7 days after the last dose of prescription medication containing narcotics
  • A medical condition, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial
  • Requiring concomitant treatment with any psychotropic drug (except zolpidem for sleep)
  • Plans to initiate or terminate any form of psychotherapy or behavior therapy during the study
  • Receiving disability payments (> 50 % service connections or total Social Security) or who are involved in litigation for PTSD or other psychiatric illnesses.
  • Unable to speak, read, and understand English or are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715519

Locations
United States, California
Veterans Affairs Long Beach Healthcare System
Long Beach, California, United States, 90822
United States, Nebraska
Veterans Affairs Nebraska Western-Iowa Healthcare Systems
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
Southern California Institute for Research and Education
Forest Laboratories
  More Information

Responsible Party: Michael Hollifield, MD, Director of Program for Traumatic Stress, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT01715519     History of Changes
Other Study ID Numbers: VII-IT-05
Study First Received: October 18, 2012
Last Updated: April 24, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Michael Hollifield, MD, Southern California Institute for Research and Education:
Vilazodone
PTSD
Depression

Additional relevant MeSH terms:
Depression
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Trauma and Stressor Related Disorders
Mental Disorders
Vilazodone Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on June 27, 2017