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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
41
VistaGen Clinical Site
Watertown, Massachusetts, United States
VistaGen Clinical Site
New York, New York, United States
Hamilton Anxiety Scale (HAM-A) Score
Least squares mean change from baseline to Visit 6 in anxiety level as measured by the HAM-A at the end of the 4-week treatment period. The HAM-A questionnaire consists of 14 items, each scored on a 5-point scale (0="Not present", 1="Mild", 2="Moderate", 3="Severe", 4="Very severe. The HAM-A total score is calculated as the sum of the 14 individual scores, ranging from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe. Higher total scores indicate more severe disease.
Time frame: 28 days
Percentage of Participants With Clinical Global Impression - Improvement Rating (CGI-I) Response
The CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item scored from 1 (Very much less anxious) to 7 (Very much more anxious) with 4 being no change. Subjects are considered CGI-I responders with scores of 1 (Very much less anxious) or 2 (Much less anxious).
Time frame: 28 days
Percentage of Participants With Patient Global Impression of Change (PGI-C) Response
The PGI-C is a self-administered instrument that measures change in subjects' overall improvement with treatment on a scale where 1= "very much improved" and 7= "very much worse". Values for comparison were the proportion of "responders" in each group, defined as subjects receiving scores of 1 (very much improved) or 2 (much improved) at the end of treatment.
Time frame: 28 days
Adjustment Disorder New Module Scale (ADNM) Score
Least squares mean change from baseline to Visit 6 in ADNM total score. THE ADNM consists of 18-item stressful life checklist and a list of 20 statements about which reactions these types of events can trigger. Subjects are asked to indicate of how often the statements apply on a 4-point scale (1= "never", 2= "rarely", 3= "sometimes", 4= "often"). ADNM total score is calculated as the sum of the 20 frequency scores. Higher total scores indicate more severe disease.
Time frame: 28 days
International Adjustment Disorder Questionnaire (IADQ) Score
Least squares mean change from baseline to Visit 6 in IADQ total score. The preoccupation, failure to adapt, and functional impairment subscale items are scored on a 5-point scale (0="Not at all", 1="A little bit", 2="Moderately", 3="Quite a bit", and 4="Extremely"). The IADQ total score is calculated as the sum of the 6 preoccupation and failure to adapt items. Higher total scores indicate more severe disease.
Time frame: 28 days
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