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Balovaptan for Post-Traumatic Stress Disorder (PTSD)

Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who have a current diagnosis of PTSD as per DSM-5 criteria, with a score of >/=33 on the PCL-5 at screening
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to week 12
Awards & highlights

Study Summary

This trial will test if a drug called balovaptan can help people with PTSD.

Eligible Conditions
  • Post-Traumatic Stress Disorder (PTSD)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with PTSD and have a high score on a questionnaire called the PCL-5.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in the Clinician-Administered PTSD Total Symptom Severity Score
Secondary outcome measures
Change from baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) total score
Change from baseline in symptom severity as measured by Clinician-Global Impression of Severity (CGI-S) after 12 weeks of treatment
Percentage of participants with adverse events

Side effects data

From 2020 Phase 1 trial • 16 Patients • NCT04156646
6%
Eye Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Balovaptan 20 mg Fasted
Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted
Balovaptan 20 mg Fed

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BalovaptanExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Balovaptan
2022
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,089,153 Total Patients Enrolled

Media Library

Balovaptan (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05401565 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Balovaptan, Placebo
Post-Traumatic Stress Disorder Clinical Trial 2023: Balovaptan Highlights & Side Effects. Trial Name: NCT05401565 — Phase 2
Balovaptan (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05401565 — Phase 2
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05401565 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any regulatory bodies sanctioned the use of Balovaptan?

"Balovaptan's safety is estimated with a score of 2, as the clinical trial it is being tested in only extends to Phase 2. This means that while there are some data indicating its security, none support the drug's efficacy."

Answered by AI

In which geographical areas can this research be accessed?

"At present, enrollment for this medical trial is available at 6 sites. These locations include Mount Kisco, Miami and Lincoln as well as 3 other cities in the vicinity. To reduce commute time it would be wise to select a site closest to you if joining the study."

Answered by AI

Is the enrollment criteria for this clinical experiment restricted to individuals aged over 25?

"Eligible participants must be over 18 years old and under 60."

Answered by AI

Are there any openings for participants in this medical trial?

"Affirmative. As per the information on clinicaltrials.gov, this clinical trial is currently accepting applicants. It was initially posted on August 2nd 2022 and recently updated on November 25th 2022. The project requires 252 participants to be recruited from 6 distinct sites."

Answered by AI

What criteria must applicants meet to be eligible for participation in this medical experiment?

"To be considered for enrolment, potential participants should have a diagnosis of moral injury and lie within the age range of 18-60. A total of 252 individuals will be accepted into this clinical study."

Answered by AI

How many participants are actively engaging in this clinical experiment?

"Hoffmann-La Roche is spearheading this trial and requires 252 eligible participants to complete it. The research will be conducted in two primary sites, Bioscience Research located in Mount Kisco, New york and Florida International Research Center based out of Miami, Florida."

Answered by AI

Who else is applying?

What state do they live in?
New York
Ohio
Illinois
Other
How old are they?
18 - 65
What site did they apply to?
Alivation Research, LLC
Bioscience Research
Other
American Medical Research, Inc
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

My psychiatrist wants me to do a trial for PTSD because I’ve been having trouble finding the right medication to help me for my PTSD.
PatientReceived 2+ prior treatments
The UT study wants to find out if low doses of the psychedelic component of mushrooms and MDMA – combined with therapy – can treat severe PTSD and depression.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What medication do you give for the study?
PatientReceived 1 prior treatment
~6 spots leftby Mar 2025