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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
Matching placebo
Alea Research
Phoenix, Arizona, United States
CITrials, Inc.
Bellflower, California, United States
ASCLEPES Research Centers
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score
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.
Time frame: From Baseline up to Week 12
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
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).
Time frame: From Baseline up to Week 12
Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score
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.
Time frame: From Baseline up to Week 12
Percentage of Participants With Adverse Events
Time frame: From Baseline up to Week 12
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Panorama City, California, United States
Clinical Innovations, Inc
Santa Ana, California, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Galiz Research, LLC
Hialeah, Florida, United States
Florida International Research Center
Miami, Florida, United States
American Medical Research, Inc
Oak Brook, Illinois, United States
Boston Clinical Trials & Medical Research
Roslindale, Massachusetts, United States
Michigan Clinical Research Institute PC - Clinedge - PPDS
Ann Arbor, Michigan, United States
...and 5 more locations