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

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

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Multicenter Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder

NCT05401565•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants who have a current diagnosis of PTSD as per DSM-5 criteria, with a score of \>/=33 on the PCL-5 at screening
•The index trauma event must have occurred in adulthood, i.e., when the participant was \>/=18 years old
•The index trauma event must have occurred at least 6 months prior to screening and no more than 10 years prior to screening
•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
•Treatment with permitted medications and/or non-pharmacological interventions at a stable dose for 6 weeks prior to screening
•For women of childbearing potential: agreement to remain abstinent or use contraception

Exclusion Criteria

•Participants who are experiencing ongoing exposure to traumatic events within 3 months of screening
•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
•Clinically significant psychiatric and/or neurological conditions, which may interfere with the assessment of safety or efficacy endpoints
•Substance use disorders during last 12 months
•Significant risk for suicidal behaviour
•Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
•Clinical diagnosis of peripheral neuropathy
•Within the last 2 years, unstable or clinically significant cardiovascular disorders
•Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
•Moderate or severe hepatic or renal impairment
+4 more criteria

Locations (15)

Alea Research

Phoenix, Arizona, United States

CITrials, Inc.

Bellflower, California, United States

ASCLEPES Research Centers

Panorama City, California, United States

Clinical Innovations, Inc

Santa Ana, California, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Galiz Research, LLC

Hialeah, Florida, United States

Florida International Research Center

Miami, Florida, United States

American Medical Research, Inc

Oak Brook, Illinois, United States

Boston Clinical Trials & Medical Research

Roslindale, Massachusetts, United States

Michigan Clinical Research Institute PC - Clinedge - PPDS

Ann Arbor, Michigan, United States

Key Dates

Start Date

August 2, 2022

Primary Completion Date

October 5, 2023

Completion Date

October 5, 2023

Last Updated

April 18, 2024

Enrollment

ACTUAL participants

Conditions

Stress Disorders, Post-Traumatic

Interventions

Balovaptan

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes

Enhancing Memory in CPT for PTSD

Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care

Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication

Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure

A Randomized Controlled Trial of Coaching Into Care With VA-CRAFT to Promote Veteran Engagement in PTSD Care