29 Participants Needed

Balovaptan for Post-Traumatic Stress Disorder (PTSD)

Recruiting at 15 trial locations
RS
Overseen ByReference Study ID Number: BN43546 https://forpatients.roche.com/
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Hoffmann-La Roche
Must be taking: Antidepressants
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a pill called balovaptan to see if it helps adults with PTSD. The study will compare the effects of balovaptan to determine its safety and effectiveness. Balovaptan works by influencing brain receptors related to emotions and social behavior.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on a stable dose of a single antidepressant (SSRI or SNRI) for PTSD, you can continue taking it as long as you've been on it for at least 6 weeks before the trial.

How does the drug Balovaptan differ from other treatments for PTSD?

Balovaptan is unique because it targets the vasopressin V1a receptor, which is different from other PTSD treatments that often focus on serotonin or monoamine pathways. This novel mechanism may offer a new approach to managing PTSD symptoms.12345

Are You a Good Fit for This Trial?

Inclusion Criteria

Treatment with permitted medications and/or non-pharmacological interventions at a stable dose for 6 weeks prior to screening
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 at least 6 months prior to screening and no more than 10 years prior to screening
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Exclusion Criteria

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.
Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 mg of oral administration balovaptan once a day or matching placebo

12 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Balovaptan
  • Placebo
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BalovaptanExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

Pimavanserin, a selective 5-HT2A inverse agonist, was tested in a rat model of PTSD and showed significant potential to reduce anxiety and stress-related symptoms, particularly in female rats exposed to stress.
The study confirmed that doses of pimavanserin effectively blocked 5-HT2A receptor activity without causing adverse effects, indicating its safety and targeted mechanism of action in alleviating PTSD-like symptoms.
Pimavanserin reverses multiple measures of anxiety in a rodent model of post-traumatic stress disorder.Malin, DH., Tsai, PH., Campbell, JR., et al.[2023]

Citations

A double-blind, randomized, placebo-controlled, multi-center study of brofaromine in the treatment of post-traumatic stress disorder. [2019]
Pimavanserin reverses multiple measures of anxiety in a rodent model of post-traumatic stress disorder. [2023]
Predictors of treatment response in patients with posttraumatic stress disorder. [2019]
Efficacy of buspirone in the treatment of posttraumatic stress disorder: an open trial. [2019]
Pharmacotherapy of post-traumatic stress disorder with a novel psychotropic. [2019]
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