Balovaptan for Post-Traumatic Stress Disorder (PTSD)

No longer recruiting at 16 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests balovaptan to determine its effectiveness in alleviating PTSD (Post-Traumatic Stress Disorder) symptoms. Participants will receive either balovaptan or a placebo (a pill with no active medicine) to compare effects. The trial aims to assess whether balovaptan can safely reduce PTSD symptoms. Individuals diagnosed with PTSD from a trauma occurring at least 6 months ago may be suitable candidates. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that balovaptan, the treatment under study for PTSD, has undergone safety testing in other studies. Most participants tolerated balovaptan well, experiencing only mild side effects such as headaches or dizziness. No major safety issues emerged, and no serious problems were linked to the drug. These findings suggest balovaptan is safe for use, although further research is ongoing to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

Unlike the standard treatments for PTSD, which usually involve therapies like SSRIs or cognitive behavioral therapy, Balovaptan offers a fresh approach by targeting the vasopressin V1a receptor. This unique mechanism of action sets it apart, as it aims to modulate social behaviors and stress responses, potentially addressing symptoms from a new angle. Researchers are excited about Balovaptan because it could provide relief for those who might not respond well to existing therapies, offering hope for more personalized treatment strategies.

What evidence suggests that balovaptan might be an effective treatment for PTSD?

Research has shown that balovaptan, a medication that blocks certain brain receptors, may help manage PTSD symptoms by targeting brain areas involved in stress. Early studies suggest that balovaptan could improve PTSD symptoms by altering how the brain handles stress and anxiety. In this trial, participants will receive either balovaptan or a placebo. Although more research is needed, these studies offer hope that balovaptan might effectively reduce PTSD symptoms in adults. ^{1 2 3 5 6}

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

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 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?

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

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.

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05401565

NCT05401565 | Study To Evaluate The Efficacy And Safety ... 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.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39531689/

Efficacy and safety of balovaptan for posttraumatic stress ... The study aimed to assess the efficacy, safety, and pharmacokinetics of balovaptan, a highly selective vasopressin 1a receptor antagonist, in adults with PTSD.

3. psycnet.apa.org psycnet.apa.org/record/2025-43465-001

Efficacy and safety of balovaptan for posttraumatic stress ... The study aimed to assess the efficacy, safety, and pharmacokinetics of balovaptan, a highly selective vasopressin 1a receptor antagonist, in adults with PTSD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10455314/

Novel Pharmacological Targets of Post-Traumatic Stress ... The results showed that most of the current pharmacological treatments for PTSD are symptom-based and show only partial benefits; this largely reflects the ...

5. withpower.com withpower.com/trial/phase-2-stress-disorders-post-traumatic-4-2022-0a2b7

Balovaptan for Post-Traumatic Stress Disorder (PTSD) 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 ...

6. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/psychiatric-disorder/ptsd/study-to-evaluate-the-efficacy-and-safety-of-balovaptan-98241.html

Clinical trial for Post Traumatic Stress Disorder-Genente... 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.