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Balovaptan for Post-Traumatic Stress Disorder (PTSD)
Study Summary
This trial will test if a drug called balovaptan can help people with PTSD.
- Post-Traumatic Stress Disorder (PTSD)
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 1 trial • 16 Patients • NCT04156646Trial Design
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Who is running the clinical trial?
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- You have mental or neurological conditions that could affect how we measure the safety or effectiveness of the treatment.You have been diagnosed with nerve damage in your limbs.You are allergic to balovaptan or any of the ingredients used to make it.You have had cancer in the past, and it is not considered fully cured.You have been diagnosed with PTSD and have a high score on a questionnaire called the PCL-5.You've been through distressing or traumatic events in the past 3 months.You must have been injured at least 6 months prior to screening.You have had problems with using drugs or alcohol in the past year.You have a high risk of attempting suicide or harmful behaviors.
- Group 1: Balovaptan
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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