Balovaptan for Post-Traumatic Stress Disorder (PTSD)

Recruiting at 15 trial locations

Overseen By Reference 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

Disqualifiers: Substance use, Suicidal risk, Epilepsy, Cardiovascular disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

29 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Eligibility Criteria

Inclusion Criteria

The index trauma event must have occurred in adulthood, i.e., when the participant was >/=18 years old

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

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

Timeline

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

Treatment Details

Interventions

• Balovaptan
• Placebo

Participant Groups

Group I: Balovaptan Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

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

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimavanserin reverses multiple measures of anxiety in a rodent model of post-traumatic stress disorder. Malin, DH., Tsai, PH., Campbell, JR., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A double-blind, randomized, placebo-controlled, multi-center study of brofaromine in the treatment of post-traumatic stress disorder. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Pimavanserin reverses multiple measures of anxiety in a rodent model of post-traumatic stress disorder. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Predictors of treatment response in patients with posttraumatic stress disorder. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of buspirone in the treatment of posttraumatic stress disorder: an open trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of post-traumatic stress disorder with a novel psychotropic. [2019]