PH94B in the Treatment of Adjustment Disorder With Anxiety
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
This placebo-controlled clinical study is designed to evaluate the efficacy, safety and
tolerability of administration of PH94B nasal spray four times per day as a treatment of
Adjustment Disorder with Anxiety symptoms in adults. Subject participation in the Study will
last a total of 6 to 10 weeks, depending on the duration of the screening period and whether
they need a washout of concomitant anxiolytics. Upon signing an investigation review board
approved informed consent, all subjects will complete Visit 1 (Screening) and enter a
screening period lasting 7 to 35 days that could include taper of concomitant anxiolytics, if
necessary. Screening visit will consist of safety assessments (medical history, physical
examination, laboratory samples, electrocardiogram, urine drug screen, and urine pregnancy
test [if appropriate]) and psychiatric assessments to determine eligibility. Subjects will
then return to complete Visit 2 (Baseline). If the subject continues to meet inclusion and
exclusion criteria, the subject will be randomized 1:1 to PH94B or placebo. Subjects will
then commence 4 weeks of double-blind treatment with randomized investigational product
(PH94B or placebo) four times per day.
Subjects will return for weekly site visits (Visits 3, 4, 5, and 6), in which the subject
will return the vial dispensed at the previous visit and receive a new vial, except at Visit
6 in which no new vial will be dispensed. Changes in AEs and concomitant medications will be
collected. During these visits, psychiatric scales will be completed. When the subject
returns for Visit 6, besides the assessments completed at Visits 3 through 5, the subjects
will complete a brief physical examination, electrocardiogram, laboratory tests (chemistry
and blood), and urinalysis. Any remaining IP vials will be collected. The subject will then
come back after a one week washout period for Follow-up visit (Visit 7).