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There is one clinical trial.
This open-label clinical study is designed to evaluate the efficacy, safety and tolerability of the PRN (on demand) administration of PH94B neuroactive nasal spray as a treatment of Adjustment Disorder with Anxiety symptoms in adults. Subject participation in the study will last a total of from eight (8) to fifteen (15) weeks, depending on the duration of the screening period. Upon signing an IRB-approved informed consent form (ICF), all subjects will complete Visit 1 and enter a screening period lasting between fourteen (14) and forty-five (45) days to determine eligibility and washout any contraindicated anti-anxiety medications. If subjects meet all eligibility criteria at the end of the screening period, subjects will complete Visit 2, the baseline visit, and will then commence four (4) weeks of open-label treatment with PH94B on an as-needed basis. During the four (4)-week treatment period, subjects will complete weekly study visits (Visits 3-6). Two (2) weeks following completion of Visit 6, subjects will complete a final safety follow-up visit (Visit 7).
Description: Questionnaire on anxiety symptoms - change from baseline
Measure: Hamilton Anxiety Scale Time: 14 daysDescription: Questionnaire on functioning - change from baseline
Measure: Sheehan Disability Scale Time: 14 daysDescription: Questionnaire on worrying etc. - change from baseline
Measure: Adjustment Disorder New Module (ADNM) Time: 14 daysDescription: Clinical impression of improvement - change from baseline
Measure: Clinical Global Impression - Improvement rating (CGI-I) Time: 14 days