Trial · NCT05401565

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

NCT05401565, Phase 2, Completed, Hoffmann-La Roche; results first posted 2024-04-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD). Trials, record NCT05401565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05401565

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
NCT number: NCT05401565
Status: Completed
Phases: Phase 2
Enrollment: 29 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Stress Disorders, Post-Traumatic
Interventions: Balovaptan, Placebo
First posted: 2022-06-02
Last updated: 2024-04-18
Results first posted: 2024-04-18

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score	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	Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score	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).
Secondary	Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score	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.
Secondary	Percentage of Participants With Adverse Events	From Baseline up to Week 12

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score	From Baseline up to Week 12	ITT Population	Score on a Scale	MEAN
SECONDARY	Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score	From Baseline up to Week 12	ITT Population	Participants	NUMBER
SECONDARY	Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score	From Baseline up to Week 12	ITT Population	Score on a Scale	MEAN
SECONDARY	Percentage of Participants With Adverse Events	From Baseline up to Week 12	Safety Population	Participants	NUMBER

Source ClinicalTrials.gov

Results by group46

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score	Placebo	Baseline	35.5	Standard Deviation 9.3	Score on a Scale
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score	Balovaptan	Baseline	33.8	Standard Deviation 7.8	Score on a Scale
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score	Placebo	Week 6	-6.8	Standard Deviation 11.2	Score on a Scale
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score	Balovaptan	Week 6	-10.3	Standard Deviation 9.2	Score on a Scale
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score	Placebo	Week 12	-15.6	Standard Deviation 10.6	Score on a Scale
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score	Balovaptan	Week 12	-17.2	Standard Deviation 10.7	Score on a Scale
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score	Placebo	Baseline Very mild	0		Participants
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score	Balovaptan	Baseline Very mild	0		Participants
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score	Placebo	Baseline Mild	1		Participants
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score	Balovaptan	Baseline Mild	0		Participants

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	16
Overall Study	STARTED	Balovaptan	13
Overall Study	COMPLETED	Placebo	13
Overall Study	COMPLETED	Balovaptan	13
Overall Study	NOT COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	Balovaptan	0

Source ClinicalTrials.gov

Adverse events108

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	PLACEBO	0	16	0
other	Constipation	Gastrointestinal disorders	BALOVAPTAN 10 MG	1	13	1
other	Diarrhoea	Gastrointestinal disorders	PLACEBO	1	16	1
other	Diarrhoea	Gastrointestinal disorders	BALOVAPTAN 10 MG	0	13	0
other	Nausea	Gastrointestinal disorders	PLACEBO	1	16	1
other	Nausea	Gastrointestinal disorders	BALOVAPTAN 10 MG	1	13	1
other	Seasonal allergy	Immune system disorders	PLACEBO	0	16	0
other	Seasonal allergy	Immune system disorders	BALOVAPTAN 10 MG	1	13	1
other	COVID-19	Infections and infestations	PLACEBO	0	16	0
other	COVID-19	Infections and infestations	BALOVAPTAN 10 MG	1	13	1

1 to 10 of 108Source ClinicalTrials.gov

See all 108 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PLACEBO	0	16
Total, all-cause mortality	BALOVAPTAN 10 MG	0	13
Total, other adverse events	PLACEBO	7	16
Total, other adverse events	BALOVAPTAN 10 MG	9	13
Total, serious adverse events	PLACEBO	0	16
Total, serious adverse events	BALOVAPTAN 10 MG	0	13

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Balovaptan vs Placebo: Percentage of Participants With Adverse Events	Trial comparisons
BALOVAPTAN 10 MG vs PLACEBO: deaths from any cause	Trial comparisons
BALOVAPTAN 10 MG vs PLACEBO: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05401565

GET https://conductscience.org/api/trials/v1/NCT05401565/results?page=2

API reference For AI assistants