Vilazodone for the Treatment of Posttraumatic Stress Disorder



Status:Completed
Conditions:Depression, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:4/26/2017
Start Date:October 2012
End Date:December 2015

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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.


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
We found this trial at
2
sites
Long Beach, California 90822
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Long Beach, CA
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Omaha, NE
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