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PH94B for Adjustment Disorder
Phase 2
Waitlist Available
Research Sponsored by VistaGen Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial is designed to study whether the administration of PH94B nasal spray four times per day is an effective treatment for Adjustment Disorder with Anxiety symptoms in adults. The trial will last 6 to 10 weeks, and subjects will be given either the PH94B spray or a placebo.
Eligible Conditions
- Adjustment Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hamilton Anxiety Scale
Secondary outcome measures
Clinical Global Impression - Improvement rating (CGI-I)
International adjustment disorder questionnaire (IADQ)
Sheehan Disability Scale
Trial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Intranasal spray four times a day for 28 days
Group II: PH94BExperimental Treatment1 Intervention
Intranasal spray 3.2 micrograms four times a day for 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
PH94B
Not yet FDA approved
Find a Location
Who is running the clinical trial?
VistaGen Therapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
1,544 Total Patients Enrolled
Frequently Asked Questions
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