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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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to week 12
Summary
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.
Eligible Conditions
- Post-Traumatic Stress Disorder (PTSD)
- Post-Traumatic Stress Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score
Secondary study objectives
Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Side effects data
From 2023 Phase 2 trial • 29 Patients • NCT0540156515%
Overdose
8%
Meniscus injury
8%
Gout
8%
Hypercholesterolaemia
8%
Constipation
8%
Nausea
8%
COVID-19
8%
Seasonal allergy
8%
Joint swelling
8%
Pharyngitis streptococcal
8%
Abnormal dreams
8%
Anxiety
8%
Dizziness
8%
Dysmenorrhoea
8%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
PLACEBO
BALOVAPTAN 10 MG
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
~80
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,459 Previous Clinical Trials
1,097,015 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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've been through distressing or traumatic events in the past 3 months.You have had problems with using drugs or alcohol in the past year.You have a high risk of attempting suicide or harmful behaviors.
Research Study Groups:
This trial has the following groups:- Group 1: Balovaptan
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05401565 — Phase 2