- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01715519
Vilazodone for the Treatment of Posttraumatic Stress Disorder
April 24, 2017 updated by: Michael Hollifield, MD, Southern California Institute for Research and Education
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
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Long Beach, California, United States, 90822
- Veterans Affairs Long Beach Healthcare System
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Nebraska
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Omaha, Nebraska, United States, 68105
- Veterans Affairs Nebraska Western-Iowa Healthcare Systems
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
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.
|
Other Names:
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Placebo Comparator: Placebo
will be compared to the treatment group (viibryd)
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD symptoms
Time Frame: four months
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PCL-C
|
four months
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PTSD Diagnosis
Time Frame: 4 months
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CAPS
|
4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: four months
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BDI-II
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four months
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Sleep
Time Frame: 4 months
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PSQI
|
4 months
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Anxiety
Time Frame: 4 months
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HSCL-25
|
4 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarkers
Time Frame: four months
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serum
|
four months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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