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NCT04404192 · ClinicalTrials.gov registry record · Phase 2
PH94B in the Treatment of Adjustment Disorder With Anxiety
A Phase 2 study of Adjustment Disorder With Anxious Mood, sponsored by VistaGen Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 2
- Study locations
NCT04404192 is a Phase 2 study of Adjustment Disorder With Anxious Mood that has completed, run by VistaGen Therapeutics. The registered enrollment target is 41 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT04404192, a Phase 2 study of Adjustment Disorder With Anxious Mood, has completed, sponsored by VistaGen Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 2
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PH94B
Study Locations (2)
Massachusetts
- VistaGen Clinical Site - Watertown
New York
- VistaGen Clinical Site - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2021-10-12 |
| Est. Completion | 2022-12-14 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04404192
The ClinicalTrials.gov registry entry for NCT04404192 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VistaGen Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Adjustment Disorder With Anxious Mood appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04404192 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT04404192 about?
NCT04404192 is a clinical study titled "PH94B in the Treatment of Adjustment Disorder With Anxiety". 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,...
What is the current status of trial NCT04404192?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2021-10-12. Estimated completion is 2022-12-14.
What conditions does trial NCT04404192 study?
This clinical trial studies the following conditions: Adjustment Disorder With Anxious Mood.
What interventions are being tested in trial NCT04404192?
The interventions under investigation include: Placebo (DRUG), PH94B (DRUG).
Who is sponsoring clinical trial NCT04404192?
This trial is sponsored by VistaGen Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04404192 being conducted?
This trial has 2 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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