Vilazodone for the Treatment of Posttraumatic Stress Disorder

Sponsor

Southern California Institute for Research and Education (Other)

Overall Status

Completed

CT.gov ID

NCT01715519

Collaborator

Forest Laboratories (Industry)

Enrollment

Locations

Arms

Duration (Months)

29.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

PTSD symptoms [four months]
PCL-C
PTSD Diagnosis [4 months]
CAPS

Secondary Outcome Measures

Depression [four months]
BDI-II
Sleep [4 months]
PSQI
Anxiety [4 months]
HSCL-25

Other Outcome Measures

Biomarkers [four months]
serum

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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:

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
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

Locations

	Site	City	State	Country	Postal Code
1	Veterans Affairs Long Beach Healthcare System	Long Beach	California	United States	90822
2	Veterans Affairs Nebraska Western-Iowa Healthcare Systems	Omaha	Nebraska	United States	68105