Vortioxetine for Posttraumatic Stress Disorder

NCT ID: NCT02637895

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-02-06

Brief 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. 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.

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo pill once daily for 12 weeks of active treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo pill matching Vortioxetine.

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.

Group Type: ACTIVE_COMPARATOR

Vortioxetine

Intervention Type: DRUG

Immediate Release 10 mg. Vortioxetine Pill

Interventions

Placebo

Placebo pill matching Vortioxetine.

Intervention Type: DRUG

Vortioxetine

Immediate Release 10 mg. Vortioxetine Pill

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males and Females between the ages of 18 and 65

2. Fulfills Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (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 Clinician Administered PTSD Scale (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, 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.

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 Obsessive Compulsive Disorder (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 (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

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,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.

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

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Philip D. Harvey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Harvey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38869978 (View on PubMed)

Dunlop 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.

Reference Type: DERIVED

PMID: 33587394 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20150534

Identifier Type: -

Identifier Source: org_study_id