For Healthcare Professionals

Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)


About the study

This study will evaluate the efficacy and safety of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults with PTSD.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Participants who have a current diagnosis of PTSD as per DSM-5 criteria, with a score of >/=33 on the PCL-5 at screening
  2. The index trauma event must have occurred in adulthood, i.e., when the participant was >/=18 years old
  3. The index trauma event must have occurred at least 6 months prior to screening and no more than 10 years prior to screening
  4. At baseline, either taking a stable dose of a single antidepressant (SSRI or SNRI) for management of PTSD and have been on that medication for >/=6 weeks at that stable dosage and demonstrating residual symptoms of PTSD or prior demonstrated lack of tolerability or lack of efficacy and not taking an antidepressant medication at baseline for >/=6 weeks
  5. Treatment with permitted medications and/or non-pharmacological interventions at a stable dose for 6 weeks prior to screening
  6. For women of childbearing potential: agreement to remain abstinent or use contraception


Exclusion Criteria:

  1. Participants who are experiencing ongoing exposure to traumatic events within 3 months of screening
  2. Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of study drug
  3. Clinically significant psychiatric and/or neurological conditions, which may interfere with the assessment of safety or efficacy endpoints
  4. Substance use disorders during last 12 months
  5. Significant risk for suicidal behaviour
  6. Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
  7. Clinical diagnosis of peripheral neuropathy
  8. Within the last 2 years, unstable or clinically significant cardiovascular disorders
  9. Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
  10. Moderate or severe hepatic or renal impairment
  11. History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic)
  12. Medical history of malignancy, if not considered cured
  13. Participants who have received treatment with investigational therapy within 8 weeks prior to randomization
  14. Known hypersensitivity to balovaptan, its components, or any of the excipients used in the formulation

pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Stress Disorders, Post-Traumatic

Age (in years)

18 - 60


Phase 2

Participants needed


Est. Completion Date

Dec 15, 2023

Treatment type



Hoffmann-La Roche identifier


Study number


Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?


Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.