Vortioxetine for Posttraumatic Stress Disorder

NCT02637895 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 20150534
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD,; trauma; stress disorder; post-traumatic stress disorder; anxiety disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Up to Week 12

Secondary Outcomes (3)

• Number of Participants That Achieve Treatment Response Via Clinician Administered PTSD Scale (CAPS)-5

  Week 12

• Change in Depressive Symptoms in PTSD

  Baseline, Up to Week 12

• Number of Participants That Achieve Treatment Response Via CGI-I

  Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo pill once daily for 12 weeks of active treatment.

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.

Drug: Vortioxetine

Interventions

Placebo DRUG

Placebo pill matching Vortioxetine.

Placebo

Vortioxetine DRUG

Immediate Release 10 mg. Vortioxetine Pill

Vortioxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• 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;

Sponsors & Collaborators

• University of Miami: lead
• Takeda: collaborator
• Emory University: collaborator

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• 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.

  PMID: 38869978 DERIVED

• 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.

  PMID: 33587394 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries; Stress Disorders, Traumatic; Anxiety Disorders

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Philip Harvey
• Organization: University of Miami Miller School of Medicine

pharvey@med.miami.edu

305 243 4094

Study Officials

• Philip Harvey, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 22, 2015
• Study Start: December 1, 2016
• Primary Completion: January 22, 2020
• Study Completion: February 6, 2020
• Last Updated: February 8, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)