CovidResearchTrials by Shray Alag


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Report for D000275: Adjustment Disorders NIH

(Synonyms: Adjustment Disorders)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug1733 PH94B Wiki 1.00
drug315 Baricitinib Wiki 0.38

Correlated MeSH Terms (0)


Name (Synonyms) Correlation

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Phase 2a Open-label Study of the Efficacy and Safety of PRN PH94B Neuroactive Nasal Spray in the Treatment of Adjustment Disorder With Anxiety (AjDA) Associated With COVID-19

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).

NCT04404192 Adjustment Disorder With Anxious Mood Drug: PH94B
MeSH:Adjustment Disorders

Primary Outcomes

Description: Questionnaire on anxiety symptoms - change from baseline

Measure: Hamilton Anxiety Scale

Time: 14 days

Secondary Outcomes

Description: Questionnaire on functioning - change from baseline

Measure: Sheehan Disability Scale

Time: 14 days

Description: Questionnaire on worrying etc. - change from baseline

Measure: Adjustment Disorder New Module (ADNM)

Time: 14 days

Description: Clinical impression of improvement - change from baseline

Measure: Clinical Global Impression - Improvement rating (CGI-I)

Time: 14 days


HPO Nodes