Evaluation of the Efficacy of Vortioxetine for Posttraumatic Stress Disorder

Investigator: Philip Harvey

Institutional Protocol #: 20150534

National Clinical Trials Identifier: NCT02637895

Funding Agency/Sponsor: Takeda

Division: Psychiatry

Therapeutic Area: Other

Phase: Approved Drug/Off-Label use

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 1/3/2017


Purpose/Abstract:


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.




Eligibility 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.


Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Jennifer Montgomery, Sr. Clinical Research Coordinator
(305) 243 3110
jjm297@miami.edu

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