Vilazodone for the Treatment of Posttraumatic Stress Disorder

NCT01715519 | Completed Phase 4 DMC

• 1 other identifier: VII-IT-05
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

PTSD; Depression

Keywords

Vilazodone; PTSD; Depression

Outcome Measures

Primary Outcomes (2)

• PTSD symptoms

  PCL-C

  four months

• PTSD Diagnosis

  CAPS

  4 months

Secondary Outcomes (3)

• Depression

  four months

• Sleep

  4 months

• Anxiety

  4 months

Other Outcomes (1)

• Biomarkers

  four months

Study Arms (2)

Treatment (Viibryd)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

will be compared to the treatment group (viibryd)

Drug: Treatment (Viibryd)

Interventions

Treatment (Viibryd) DRUG

Also known as: Vilazodone

Placebo; Treatment (Viibryd)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with a concurrent DSM-IV Axis I diagnosis in any of the following categories:
• Delirium, Dementia, Amnestic and other Cognitive disorders
• Lifetime Schizophrenia and other Psychotic Disorders
• lifetime Bipolar I Disorder
• Bipolar-II Disorder with an episode of hypomania within the last year
• Alcohol or Substance Dependence or Abuse (excluding nicotine) in one month prior to the Screening Visit
• 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

Sponsors & Collaborators

• Southern California Institute for Research and Education: lead
• Forest Laboratories: collaborator

Study Sites (2)

Veterans Affairs Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

Veterans Affairs Nebraska Western-Iowa Healthcare Systems

Omaha, Nebraska, 68105, United States

Location

Related Publications (1)

• 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.

  PMID: 28858440 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Therapeutics; Vilazodone Hydrochloride

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Program for Traumatic Stress

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)