PTSDPhase 4NCT01715519
Vilazodone for the Treatment of Posttraumatic Stress Disorder
A Phase 4 study testing Treatment (Viibryd) in people with PTSD and Depression, run by Southern California Institute for Research and Education at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- PTSD, Depression
- What is being tested?
- Treatment (Viibryd)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans Affairs Long Beach Healthcare System
Long Beach, California, 90822
Veterans Affairs Nebraska Western-Iowa Healthcare Systems
Omaha, Nebraska, 68105
About this study
Official title: 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.
- Conditions
- PTSD, Depression
- Being tested
- Treatment (Viibryd)
- Keywords
- Vilazodone, PTSD, Depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment (Viibryd)Drug
Also called Vilazodone
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Treatment (Viibryd) |
| Placebo | Placebo comparator | will be compared to the treatment group (viibryd) Receives: Drug: Treatment (Viibryd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms
PCL-C
Measured: four months
PTSD Diagnosis
CAPS
Measured: 4 months
Secondary outcomes (3)
Depression
BDI-II
Measured: four months
Sleep
PSQI
Measured: 4 months
Anxiety
HSCL-25
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Michael Hollifield, MD, Southern California Institute for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715519
- Sponsor's protocol ID
- VII-IT-05
- Status last verified
- Apr 2017
- First submitted
- 18 Oct 2012
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28858440
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Randomized Trial of Vilazodone in the Treatment of Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01715519
- Acronym / sponsor ID
- VII-IT-05
- Conditions
- PTSD, Depression
- Keywords
- Vilazodone, PTSD, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Oct 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (Viibryd) | Experimental | Drug: 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. |
| Placebo | Placebo comparator | Drug: Treatment (Viibryd)will be compared to the treatment group (viibryd) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- Patients with a concurrent DSM-IV Axis I diagnosis in any of the following categories:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment (Viibryd)Also: Vilazodone | Drug | Placebo, Treatment (Viibryd) |
Primary outcome
PTSD symptoms
Time frame: four months
PCL-C
PTSD Diagnosis
Time frame: 4 months
CAPS
3 secondary outcomes
Depression
Time frame: four months
Sleep
Time frame: 4 months
Anxiety
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Derived from this study: PubMed 28858440Ramaswamy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment (Viibryd) in people with PTSD and Depression, run by Southern California Institute for Research and Education at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptoms (time frame: four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.