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Vortioxetine for Posttraumatic Stress Disorder

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Philip D. Harvey, University of Miami
Sponsor:
Collaborators:
Takeda
Emory University
Information provided by (Responsible Party):
Philip D. Harvey, University of Miami
ClinicalTrials.gov Identifier:
NCT02637895
First received: December 15, 2015
Last updated: May 2, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention Phase
Post-Traumatic Stress Disorder Drug: Placebo Drug: Vortioxetine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Vortioxetine for Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Philip D. Harvey, University of Miami:

Primary Outcome Measures:
  • An improved PTSD scale score [ Time Frame: From Baseline to Week 12 ]
    Mean changes in the Clinician-Administered PTSD Scale (CAPS)


Secondary Outcome Measures:
  • A 50% improved overall response rate on a PTSD scaled score. [ Time Frame: From Baseline to Week 12 ]
    50% improvement from baseline in the Clinically-Administered PTSD Scale (CAPS).

  • Reduction in depressive symptoms in PTSD [ Time Frame: From Baseline to Week 12 ]
    Determined by mean changes by the Montgomery-Asberg Depression Rating Scale (MADRS).

  • 50% improvement in CGI-Score [ Time Frame: From Baseline to Week 12 ]
    50% improvement in Clinical Global Impression of Improvement (CGI-I) score of 1 or 2.


Estimated Enrollment: 80
Study Start Date: December 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo pill once daily for 12 weeks of active treatment.
Drug: Placebo
Active Comparator: Vortioxetine
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.
Drug: Vortioxetine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  1. Males and Females between the ages of 18 and 65
  2. Fulfills DSM-5 criteria for primary diagnosis of PTSD.
  3. Able to give consent
  4. Willingness to sign the treatment contract
  5. A negative urine toxicology
  6. For females of reproductive age, use of an effective birth control method* for the duration of the study or abstinence.
  7. Duration of illness of PTSD for at least 3 months
  8. An initial score at Screening, and Visit 3 (randomization) of ≥ 50 on the CAPS for PTSD Studies

Exclusion

  1. Lifetime or current diagnosis of schizophrenia or other psychotic disorder, dementia, bipolar disorder.
  2. 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.
  3. Current evidence or history of significant unstable medical illness or organic brain impairment, including stroke, 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 TBI will also be exclusionary.
  4. Patients who in the investigator's judgment pose a current suicidal or homicidal risk
  5. DSM-5 substance abuse or dependence within the past 90 days. Subject has a positive urine toxicology test for illegal substances.
  6. Diagnosis of anorexia nervosa, bulimia, or OCD in the past year.
  7. 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 (ALT, AST, ALP), or total or direct bil > 1.5 x ULN, unless consistent with presumed or diagnosed Gilbert's disease
  8. Subject has taken systemic corticosteroids within 2 weeks of the Randomization Visit
  9. Treatment with any other psychoactive medication within 2 weeks of Visit 1, including all antidepressants, psychoactive herbal or nutritional treatment (St Johns Wort, 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.
  10. Pregnancy or lactation*
  11. 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).
  12. Any laboratory abnormality that in the investigator's judgment is considered to be clinically significant (blood pressure, ECG, TSH, LFT, etc.)
  13. Patients who are receiving exposure-based psychotherapy that targets PTSD symptoms
  14. Current or planned litigation or other actions related to secondary gain regarding the traumatic event
  15. Subject has clinical evidence of, or 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:

    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02637895

Contacts
Contact: Gabriela Vargas, B.S 305-243-2708 gvargas3@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Gabriela Vargas, B.S    305-243-2708    gvargas3@med.miami.edu   
Principal Investigator: Philip Harvey, PhD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jaclyn W Gray    404-778-6663    jaclyn.gray@emory.edu   
Principal Investigator: Boadie W Dunlop, M.D         
Sponsors and Collaborators
University of Miami
Takeda
Emory University
Investigators
Principal Investigator: Philip Harvey, PhD University of Miami
  More Information

Responsible Party: Philip D. Harvey, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02637895     History of Changes
Other Study ID Numbers: 20150534
Study First Received: December 15, 2015
Last Updated: May 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Philip D. Harvey, University of Miami:
PTSD,
trauma
stress disorder
post-traumatic stress disorder
anxiety disorder

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Vortioxetine
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists
Serotonin 5-HT3 Receptor Antagonists

ClinicalTrials.gov processed this record on September 19, 2017