Vilazodone for the Treatment of Posttraumatic Stress Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; PTSD
• Intervention / Treatment: Drug: Treatment (Viibryd)

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90822
      • Veterans Affairs Long Beach Healthcare System
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Veterans Affairs Nebraska Western-Iowa Healthcare Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Vilazodone
Placebo Comparator: Placebo; will be compared to the treatment group (viibryd)	Drug: Treatment (Viibryd); Other Names: Vilazodone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD symptoms	PCL-C	four months
PTSD Diagnosis	CAPS	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	BDI-II	four months
Sleep	PSQI	4 months
Anxiety	HSCL-25	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	serum	four months

Collaborators and Investigators

• Sponsor: Southern California Institute for Research and Education
• Collaborators: Forest Laboratories

Publications and helpful links

General Publications

• Ramaswamy S, Driscoll D, Reist C, Smith LM, Albers LJ, Rose J, Nguyen L, Monga V, Doria R, Hollifield M. A Double-Blind, Placebo-Controlled Randomized Trial of Vilazodone in the Treatment of Posttraumatic Stress Disorder and Comorbid Depression. Prim Care Companion CNS Disord. 2017 Aug 24;19(4):17m02138. doi: 10.4088/PCC.17m02138.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: PTSD; Depression; Vilazodone
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Depression; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vilazodone Hydrochloride
• Other Study ID Numbers: VII-IT-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No