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).
Full Title of Study: “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″
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 2021
- Drug: PH94B
- Intranasal administration up to 4 times a day as needed for anxiety
Arms, Groups and Cohorts
- Experimental: PH94B
- Intranasal spray 3.2 micrograms up to four times a day as needed for anxiety for 14 days.
Clinical Trial Outcome Measures
- Hamilton Anxiety Scale
- Time Frame: 14 days
- Questionnaire on anxiety symptoms – change from baseline
- Sheehan Disability Scale
- Time Frame: 14 days
- Questionnaire on functioning – change from baseline
- Adjustment Disorder New Module (ADNM)
- Time Frame: 14 days
- Questionnaire on worrying etc. – change from baseline
- Clinical Global Impression – Improvement rating (CGI-I)
- Time Frame: 14 days
- Clinical impression of improvement – change from baseline
Participating in This Clinical Trial
1. Male and female adults, 18 through 75 years of age, inclusive.
2. Current diagnosis of Adjustment Disorder with Anxiety (AjDA) as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
3. Clinician-rated Hamilton Anxiety Rating Scale (HAM-A) score ≥20 at both Screening (Visit 1) and Baseline (Visit 2) visits.
4. Clinician-rated Hamilton Depression Rating Scale (HAM-D17) total score <18 at both Screening and Baseline visits.
5. Clinical Global Impression – Severity Scale (CGI-S) score ≥4 at both Screening and Baseline visits.
6. Women of child-bearing-potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study, and must also have a negative urine pregnancy test result at both Screening and Baseline visits, prior to study drug administration. Effective methods of contraception include: condoms with spermicide; diaphragm with spermicide; hormonal contraceptive agents (oral, transdermal; or injectable) or implantable contraceptive devices.
1. Any history of schizophrenia or schizoaffective disorder.
2. Any other current Axis I disorder, including, but not limited to, Major Depressive Disorder (MDD), Bipolar disorder (BD), Post-Traumatic Stress Disorder (PTSD), Obsessive-Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), which is in poor control and the primary focus of treatment.
3. A primary diagnosis of social anxiety disorder (SAD) with a score >60 on the Liebowitz Social Anxiety Disorder Scale.
4. Subjects who meet criteria for moderate or severe alcohol or substance use disorder within the one (1) year prior to study entry.
5. In the opinion of the Investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study, or:
1. At Screening: the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C SSRS) with reference to a six (6)-month period prior to screening; or
2. At Screening: the subject has had one (1) or more suicidal attempts with reference to a teo (2)-year period prior to screening; or
3. At Baseline: the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to screening; or
4. Considered to be an imminent danger to themself or others.
6. Currently testing positive for SARS-CoV-2 or currently suffering from COVID-19
7. Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
8. An acute or chronic condition, including an infectious illness, uncontrolled seasonal allergies at the time of the study, or significant nasal congestion that potentially could affect drug delivery to the nasal chemosensory epithelium. The Investigator may allow concomitant use of over-the-counter (OTC) nasal decongestants as needed, since there is no interaction between these and PH94B (PH94B PER 01A).
9. Concomitant use of any anxiolytic, such as a benzodiazepine or buspirone, during the study and within thirty (30) days prior to study entry.
10. Concomitant use of any OTC, prescription product, or herbal preparation such as cannabidiol, for treatment of the symptoms of anxiety during the study and within thirty (30) days prior to study entry.
11. Women who have a positive urine pregnancy test prior to study drug administration.
12. Subjects with clinically significant abnormalities in hematology, blood chemistry, urinalysis, electrocardiogram (ECG), or physical examination identified at Screening or Baseline that in the clinical judgment of the Investigator, could place the subject at undue risk, interfere with study participation, or confound the results of the study.
13. Subjects with a positive urine drug screen at either Screening or Baseline.
14. Any current clinically significant and/or uncontrolled medical condition that, in the clinical judgment of the Investigator, could place the subject at undue risk, interfere with study participation, or confound the results of the study.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- VistaGen Therapeutics, Inc.
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Matt Turzilli, 212-595-5012, email@example.com
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