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Completed

NCT Number: NCT05401565

Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alea Research, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 in adulthood, i.e., when the participant was >/=18 years old
  • The index trauma event must have occurred at least 6 months prior to screening and no more than 10 years prior to screening
  • At baseline, either taking a stable dose of a single antidepressant (SSRI or SNRI) for management of PTSD and have been on that medication for >/=6 weeks at that stable dosage and demonstrating residual symptoms of PTSD or prior demonstrated lack of tolerability or lack of efficacy and not taking an antidepressant medication at baseline for >/=6 weeks
  • Treatment with permitted medications and/or non-pharmacological interventions at a stable dose for 6 weeks prior to screening
  • For women of childbearing potential: agreement to remain abstinent or use contraception

Exclusion criteria

  • Participants who are experiencing ongoing exposure to traumatic events within 3 months of screening
  • Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of study drug
  • Clinically significant psychiatric and/or neurological conditions, which may interfere with the assessment of safety or efficacy endpoints
  • Substance use disorders during last 12 months
  • Significant risk for suicidal behaviour
  • Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
  • Clinical diagnosis of peripheral neuropathy
  • Within the last 2 years, unstable or clinically significant cardiovascular disorders
  • Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
  • Moderate or severe hepatic or renal impairment
  • History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic)
  • Medical history of malignancy, if not considered cured
  • Participants who have received treatment with investigational therapy within 8 weeks prior to randomization
  • Known hypersensitivity to balovaptan, its components, or any of the excipients used in the formulation

Treatment and study plan

Balovaptan

Drug

Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period

Placebo

Drug

Matching placebo

Primary outcomes

  1. Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score

    Time frame: From Baseline up to Week 12

    The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. Measured 3 times over 12 weeks.

Secondary outcomes

  1. Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score

    Time frame: From Baseline up to Week 12

    The CGI-S reflects the rater's impression of the subject's current PTSD severity on a 6-point scale ranging from no symptoms (1) to very severe symptoms (6).

  2. Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score

    Time frame: From Baseline up to Week 12

    PHQ-9 is a 9-item PRO used to assess severity of depression. Responses are rated based on frequency of symptoms on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). A total PHQ-9 total score ranging from 0 to 27 can be calculated by summing the nine items, of which a higher score corresponds to more severe depression.

  3. Percentage of Participants With Adverse Events

    Time frame: From Baseline up to Week 12

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Multicenter Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2022
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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