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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 weeks
Treatment ~ Varies
Follow Up ~from baseline up to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to week 12 for reporting.

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 • NCT05401565
15%
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
2,452 Previous Clinical Trials
1,096,274 Total Patients Enrolled

Media Library

Balovaptan (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05401565 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Balovaptan, Placebo
Post-Traumatic Stress Disorder Clinical Trial 2023: Balovaptan Highlights & Side Effects. Trial Name: NCT05401565 — Phase 2
Balovaptan (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05401565 — Phase 2
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05401565 — Phase 2
~9 spots leftby Nov 2025
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