Vilazodone for the Treatment of Posttraumatic Stress Disorder

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