Post-Traumatic Stress DisorderPhase 4NCT02637895
Vortioxetine for Posttraumatic Stress Disorder
A Phase 4 study testing Vortioxetine in people with Post-Traumatic Stress Disorder, run by University of Miami at 2 sites in United States.
Trial summary
Post-traumatic stress disorder (PTSD) can result from having experienced or witnessed a traumatic event. Patients with PTSD symptoms can sometimes experience symptom relief after treatment with antidepressants; however, few patients experience complete symptom relief. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Vortioxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to 6 Feb 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females between the ages of 18 and 65
- Fulfills Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for primary diagnosis of PTSD.
- Able to give consent
- Willingness to sign the treatment contract
- A negative urine toxicology
- For females of reproductive age, use of an effective birth control method* for the duration of the study or abstinence.
- Duration of illness of PTSD for at least 3 months
- An initial score at Screening, and Visit 3 (randomization) of ≥ 50 on the Clinician Administered PTSD Scale (CAPS) for PTSD Studies
Who cannot join
- Lifetime or current diagnosis of schizophrenia or other psychotic disorder, dementia, bipolar disorder.
- Subject is currently participating in another clinical trial in which s/he is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month.
- Current evidence or history of significant unstable medical illness or organic brain impairment, including stroke, Central Nervous System (CNS) tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment that would likely interfere with the action, absorption, distribution, metabolism, or excretion of Vortioxetine. History of moderate or more severe Traumatic Brain Injury (TBI) will also be exclusionary.
- Patients who in the investigator's judgment pose a current suicidal or homicidal risk
- DSM-5 substance abuse or dependence within the past 90 days. Subject has a positive urine toxicology test for illegal substances.
- Diagnosis of anorexia nervosa, bulimia, or Obsessive Compulsive Disorder (OCD) in the past year.
Show all 17Show fewer
- Subject has a documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen and/or hepatitis C antibody), and clinically significant hepatic enzyme elevation, including any one of the following enzymes greater than 3 times the upper limit of normal (ULN) value (Alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase( ALP)), or total or direct bilirubin > 1.5 x ULN, unless consistent with presumed or diagnosed Gilbert's disease
- Subject has taken systemic corticosteroids within 2 weeks of the Randomization Visit
- Treatment with any other psychoactive medication within 2 weeks of Visit 1, including all antidepressants, psychoactive herbal or nutritional treatment (St Johns Wort,S-Adenosyl methionine(SAM-e)), lithium, other mood stabilizers, oral antipsychotics, depot antipsychotics within 12 weeks, beta blockers, thioridazine, pimozide, opiates, anxiolytics, and sedatives (with the exception of zolpidem, eszopiclone, and zaleplon). Also any treatment with any medication that the PI judges not acceptable for this study.
- Pregnancy or lactation*
- Subjects who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures (e.g. illiteracy, planned vacations, or planned hospitalizations during the study).
- Any laboratory abnormality that in the investigator's judgment is considered to be clinically significant
- Patients who are receiving exposure-based psychotherapy that targets PTSD symptoms
- Current or planned litigation or other actions related to secondary gain regarding the traumatic event
- Subject has clinical evidence of, or ElectroCardiogram (ECG) results indicating any of the following at either screen or Randomization Visit unless repeat ECG shows that the parameter had returned to within normal range by the Randomization Visit:
- Q to T interval change (QTc)> 450 msec for men, or > 475 msec for women;
- any cardiac condition or ECG evidence that the investigator feels may pose a potential safety concern.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia, 30322
University of Miami
Miami, Florida, 33136
About this study
Official title: Evaluation of the Efficacy of Vortioxetine for Posttraumatic Stress Disorder
Post-traumatic stress disorder (PTSD) can result from having experienced or witnessed a traumatic event. Patients with PTSD symptoms can sometimes experience symptom relief after treatment with antidepressants; however, few patients experience complete symptom relief. There is a need to develop new treatments for PTSD.
This study will evaluate if 12 weeks of using Vortioxetine relieves PTSD symptoms. Vortioxetine has been approved for the treatment of depression; however, Vortioxetine has not been approved by the Food and Drug Administration for the treatment of PTSD.
Read the detailed description
Patients included in the study will either take the study medication or will take a placebo, a pill without the active medication. This will be determined by chance like a flip of a coin.
Study procedures will include taking study medication and coming to regular in-clinic visits. Depending on the study visit, study tests may include the following: medical evaluations, physical exams, body measurements, vital signs, blood and urine tests, pregnancy tests, genetic testing, heart function monitoring, clinical and psychiatric measures, neuropsychological testing (for example, investigators will test how well you remember words or how fast you perform a certain task), a function test (for example, investigators will test how well you perform certain daily tasks), and a test to measure your startle response. A startle response is an unexpected response by a sudden activity.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Placebo, Vortioxetine
- Keywords
- PTSD,, trauma, stress disorder, post-traumatic stress disorder, anxiety disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries, Stress Disorders, Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo pill matching Vortioxetine.
VortioxetineDrug
Immediate Release 10 mg. Vortioxetine Pill
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo pill once daily for 12 weeks of active treatment. Receives: Drug: Placebo |
| Vortioxetine | Active comparator | Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12. Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Clinician Administered PTSD Scale Score
Clinician-Administered PTSD Scale (CAPS-5) has a total score ranging from 0-80 with the higher score indicating greater degree of PTSD symptom severity.
Measured: Baseline, Up to Week 12
Secondary outcomes (3)
Number of Participants That Achieve Treatment Response Via Clinician Administered PTSD Scale (CAPS)-5
Number of participants that achieve treatment response will be reported as those that has achieved a 30% improvement in their CAPS-5 total score from baseline. CAPS-5 has a total score ranging from 0-80 with the higher score indicating greater degree of PTSD symptom severity. Observed cases only.
Measured: Week 12
Change in Depressive Symptoms in PTSD
Montgomery-Asberg Depression Rating Scale (MADRS) has a total score ranging from 0-60, with 0 meaning no depressive symptoms and 60 meaning severe depressive symptoms.(MADRS). From the total score 0-60, with 0 meaning no depressive symptoms and 60 meaning severe depressive symptoms.
Measured: Baseline, Up to Week 12
Number of Participants That Achieve Treatment Response Via CGI-I
Clinical Global Impression of Improvement (CGI-I) is a 7 point Likert-scale questionnaire assessing PTSD symptoms improvement. A score of 1 indicates very much improved, 4 indicates no change and 7 indicates much worse. Treatment response will be reported as the number of participants with an improvement of 1-2 points on their CGI-I score from baseline. Analysis includes observed cases only.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2016
- Primary completion22 Jan 2020
- Study completion6 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda, Emory University
- Responsible party
- Principal investigator, Philip D. Harvey, University of Miami
- Investigators
- Philip Harvey, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637895
- Sponsor's protocol ID
- 20150534
- Status last verified
- Jan 2021
- First submitted
- 15 Dec 2015
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guidetti C, Feeney A, Hock RS, Iovieno N, Hernandez Ortiz JM, Fava M, Papakostas GI. Antidepressants in the acute treatment of post-traumatic stress disorder in adults: a systematic review and meta-analysis. Int Clin Psychopharmacol. 2025 May 1;40(3):138-147. doi: 10.1097/YIC.0000000000000554. Epub 2024 Jun 14.
PubMed 38869978Dunlop BW, Rakofsky JJ, Newport DJ, Mletzko-Crowe T, Barone K, Nemeroff CB, Harvey PD. Efficacy of Vortioxetine Monotherapy for Posttraumatic Stress Disorder: A Randomized, Placebo-Controlled Trial. J Clin Psychopharmacol. 2021 Mar-Apr 01;41(2):172-179. doi: 10.1097/JCP.0000000000001363.
PubMed 33587394
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Vortioxetine for Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02637895
- Acronym / sponsor ID
- 20150534
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD,, trauma, stress disorder, post-traumatic stress disorder, anxiety disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Takeda, Emory University
- Study start
- Dec 2016 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 8 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-traumatic stress disorder (PTSD) can result from having experienced or witnessed a traumatic event. Patients with PTSD symptoms can sometimes experience symptom relief after treatment with antidepressants; however, few patients experience complete symptom relief. There is a need to develop new treatments for PTSD.
This study will evaluate if 12 weeks of using Vortioxetine relieves PTSD symptoms. Vortioxetine has been approved for the treatment of depression; however, Vortioxetine has not been approved by the Food and Drug Administration for the treatment of PTSD.
Detailed description
Patients included in the study will either take the study medication or will take a placebo, a pill without the active medication. This will be determined by chance like a flip of a coin.
Study procedures will include taking study medication and coming to regular in-clinic visits. Depending on the study visit, study tests may include the following: medical evaluations, physical exams, body measurements, vital signs, blood and urine tests, pregnancy tests, genetic testing, heart function monitoring, clinical and psychiatric measures, neuropsychological testing (for example, investigators will test how well you remember words or how fast you perform a certain task), a function test (for example, investigators will test how well you perform certain daily tasks), and a test to measure your startle response. A startle response is an unexpected response by a sudden activity.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pill once daily for 12 weeks of active treatment. |
| Vortioxetine | Active comparator | Drug: VortioxetineVortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and Females between the ages of 18 and 65
- Fulfills Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for primary diagnosis of PTSD.
- Able to give consent
- Willingness to sign the treatment contract
- A negative urine toxicology
Key exclusion criteria (17 listed)
- Lifetime or current diagnosis of schizophrenia or other psychotic disorder, dementia, bipolar disorder.
- Subject is currently participating in another clinical trial in which s/he is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month.
- Current evidence or history of significant unstable medical illness or organic brain impairment, including stroke, Central Nervous System (CNS) tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment that would likely interfere with the action, absorption, distribution, metabolism, or excretion of Vortioxetine. History of moderate or more severe Traumatic Brain Injury (TBI) will also be exclusionary.
- Patients who in the investigator's judgment pose a current suicidal or homicidal risk
- DSM-5 substance abuse or dependence within the past 90 days. Subject has a positive urine toxicology test for illegal substances.
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 |
|---|---|---|
| PlaceboPlacebo pill matching Vortioxetine. | Drug | Placebo |
| VortioxetineImmediate Release 10 mg. Vortioxetine Pill | Drug | Vortioxetine |
Primary outcome
Change Clinician Administered PTSD Scale Score
Time frame: Baseline, Up to Week 12
Clinician-Administered PTSD Scale (CAPS-5) has a total score ranging from 0-80 with the higher score indicating greater degree of PTSD symptom severity.
3 secondary outcomes
Number of Participants That Achieve Treatment Response Via Clinician Administered PTSD Scale (CAPS)-5
Time frame: Week 12
Change in Depressive Symptoms in PTSD
Time frame: Baseline, Up to Week 12
Number of Participants That Achieve Treatment Response Via CGI-I
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38869978Guidetti C, Feeney A, Hock RS, Iovieno N, Hernandez Ortiz JM, Fava M, Papakostas GI. Antidepressants in the acute treatment of post-traumatic stress disorder in adults: a systematic review and meta-analysis. Int Clin Psychopharmacol. 2025 May 1;40(3):138-147. doi: 10.1097/YIC.0000000000000554. Epub 2024 Jun 14.
- Derived from this study: PubMed 33587394Dunlop BW, Rakofsky JJ, Newport DJ, Mletzko-Crowe T, Barone K, Nemeroff CB, Harvey PD. Efficacy of Vortioxetine Monotherapy for Posttraumatic Stress Disorder: A Randomized, Placebo-Controlled Trial. J Clin Psychopharmacol. 2021 Mar-Apr 01;41(2):172-179. doi: 10.1097/JCP.0000000000001363.
- Individual participant dataSharing planned: No
Related trials for Post-Traumatic Stress Disorder
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
Not yet recruiting
RISE for PTSD and Substance Use Disorder in Veterans
Stress Disorders, Post-Traumatic, Substance-Related Disorders
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Recruiting
Recovering Sleep After Trauma
Post-traumatic Stress Disorder
Not yet recruitingPhase 2
Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD
PTSD - Post Traumatic Stress Disorder
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.
Philip Harvey, PhD principal investigator
University of Miami
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 Vortioxetine in people with Post-Traumatic Stress Disorder, run by University of Miami 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 17 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 8 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change Clinician Administered PTSD Scale Score (time frame: Baseline, Up to Week 12). 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 NCT02637895, which also lists 2 linked publications.
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 8 Feb 2021.