Adjustment Disorder With Anxious MoodPhase 2NCT04404192
PH94B in the Treatment of Adjustment Disorder With Anxiety
A Phase 2 study testing PH94B in people with Adjustment Disorder With Anxious Mood, run by VistaGen Therapeutics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adjustment Disorder With Anxious Mood
- What is being tested?
- PH94B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Oct 2021to 14 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent provided prior to conducting any study-specific assessment.
- Male and female adults, 18 through 65 years of age, inclusive.
- Current diagnosis of AjDA as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.
- Clinician-rated Hamilton Anxiety Scale (HAM-A) score ≥20 at Screening (Visit 1) and no greater than 15% decrease at Baseline (Visit 2).
- Clinician-rated Hamilton Depression Scale (HAM-D) total score <18 at Screening (Visit 1) and Baseline (Visit 2).
- Clinical Global Impression - Severity Scale (CGI-S) score ≥4 at both Screening (Visit 1) and Baseline (Visit 2)
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- 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 (Visit 1) and Baseline (Visit 2), prior to investigational product (IP) administration. Effective methods of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices.
- Males whose sexual partners are women of childbearing potential must commit to the consistent and correct use of an effective method of birth control throughout the study.
- Negative COVID-19 test either in the presence of COVID-19 symptoms or after exposure to someone with a positive COVID-19 test.
Who cannot join
- Any history of schizophrenia or schizoaffective disorder.
- Any other current Axis I disorder, including, but not limited to, major depressive disorder, bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder, premenstrual dysphoric disorder, and generalized anxiety disorder, which is in poor control and the primary focus of treatment.
- A diagnosis of social anxiety disorder with a score >60 on the Liebowitz Social Anxiety Scale.
- Subjects who meet criteria for moderate or severe alcohol or substance use disorder within the 1 year prior to Study entry.
- 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 considered to be an imminent danger to themselves or others.
- Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
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- 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 nasal decongenstants as needed, since there is no apparent drug interaction between these and PH94B.
- Concomitant use of any anxiolytics, such as benzodiazepines or buspirone, during the Study and within 30 days of Baseline (Visit 2).
- Concomitant use of any over-the-counter, prescription product, or herbal preparation for treatment of the symptoms of anxiety during the Study and within 30 days before Study entry. Selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, or other approved antidepressants are permitted as long as the dose has been stable for 30 days prior to Baseline (Visit 2).
- Women who have a positive urine or serum pregnancy test at either Screening or Baseline visit or are currently breast feeding.
- Subjects with clinically significant abnormalities in hematology, blood chemistry, urinalysis, electrocardiogram, or physical examination identified at the Screening visit 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.
- Subjects with a positive urine drug screen at either the Screening visit or Baseline visit (not including tetrahydrocannabinol).
- Any current clinically significant and/or uncontrolled medical condition, based on medical history or as evidenced in screening assessments, such as SARS-Cov-2, HIV, cancer, stroke, congestive heart failure, uncontrolled diabetes mellitus, or any other medical condition or disease 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.
- Use of a concomitant medication that, in the clinical judgement of the Investigator, could place the subject at undue risk, interfere with study participation, or confound the results of the study.
- History of cancer or malignant tumor not in remission for at least 2 years. Basal cell skin cancers are not exclusionary.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VistaGen Clinical Site
New York, New York, 10128
VistaGen Clinical Site
Watertown, Massachusetts, 02472
About this study
Official title: A Phase 2a Double-blind, Placebo-controlled, Parallel Study of PH94B Nasal Spray 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, 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
- Adjustment Disorder With Anxious Mood
- Being tested
- PH94B, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH94BDrug
Also called Aloradine
Intranasal administration of 100 microliters to each nostril 4 times a day
PlaceboDrug
Intranasal administration of 100 microliters to each nostril 4 times a day.
| Study group | Role | What they receive |
|---|---|---|
| PH94B | Experimental | Intranasal spray 3.2 micrograms four times a day for 28 days Receives: Drug: PH94B |
| Placebo | Experimental | Intranasal spray four times a day for 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Scale (HAM-A) Score
Least squares mean change from baseline to Visit 6 in anxiety level as measured by the HAM-A at the end of the 4-week treatment period. The HAM-A questionnaire consists of 14 items, each scored on a 5-point scale (0="Not present", 1="Mild", 2="Moderate", 3="Severe", 4="Very severe. The HAM-A total score is calculated as the sum of the 14 individual scores, ranging from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe. Higher total scores indicate more severe disease.
Measured: 28 days
Secondary outcomes (4)
Percentage of Participants With Clinical Global Impression - Improvement Rating (CGI-I) Response
The CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item scored from 1 (Very much less anxious) to 7 (Very much more anxious) with 4 being no change. Subjects are considered CGI-I responders with scores of 1 (Very much less anxious) or 2 (Much less anxious).
Measured: 28 days
Percentage of Participants With Patient Global Impression of Change (PGI-C) Response
The PGI-C is a self-administered instrument that measures change in subjects' overall improvement with treatment on a scale where 1= "very much improved" and 7= "very much worse". Values for comparison were the proportion of "responders" in each group, defined as subjects receiving scores of 1 (very much improved) or 2 (much improved) at the end of treatment.
Measured: 28 days
Adjustment Disorder New Module Scale (ADNM) Score
Least squares mean change from baseline to Visit 6 in ADNM total score. THE ADNM consists of 18-item stressful life checklist and a list of 20 statements about which reactions these types of events can trigger. Subjects are asked to indicate of how often the statements apply on a 4-point scale (1= "never", 2= "rarely", 3= "sometimes", 4= "often"). ADNM total score is calculated as the sum of the 20 frequency scores. Higher total scores indicate more severe disease.
Measured: 28 days
International Adjustment Disorder Questionnaire (IADQ) Score
Least squares mean change from baseline to Visit 6 in IADQ total score. The preoccupation, failure to adapt, and functional impairment subscale items are scored on a 5-point scale (0="Not at all", 1="A little bit", 2="Moderately", 3="Quite a bit", and 4="Extremely"). The IADQ total score is calculated as the sum of the 6 preoccupation and failure to adapt items. Higher total scores indicate more severe disease.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start12 Oct 2021
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adjustment Disorder With Anxious MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- VistaGen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404192
- Sponsor's protocol ID
- PH94B-CL029
- Status last verified
- Jan 2026
- First submitted
- 21 May 2020
- Last updated
- 5 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Double-blind, Placebo-controlled, Parallel Study of PH94B Nasal Spray in the Treatment of Adjustment Disorder With Anxiety
- ClinicalTrials.gov ID
- NCT04404192
- Acronym / sponsor ID
- PH94B-CL029
- Conditions
- Adjustment Disorder With Anxious Mood
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- VistaGen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Posted 5 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PH94B | Experimental | Drug: PH94BIntranasal spray 3.2 micrograms four times a day for 28 days |
| Placebo | Experimental | Drug: PlaceboIntranasal spray four times a day for 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent provided prior to conducting any study-specific assessment.
- Male and female adults, 18 through 65 years of age, inclusive.
- Current diagnosis of AjDA as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.
- Clinician-rated Hamilton Anxiety Scale (HAM-A) score ≥20 at Screening (Visit 1) and no greater than 15% decrease at Baseline (Visit 2).
- Clinician-rated Hamilton Depression Scale (HAM-D) total score <18 at Screening (Visit 1) and Baseline (Visit 2).
Key exclusion criteria (15 listed)
- Any history of schizophrenia or schizoaffective disorder.
- Any other current Axis I disorder, including, but not limited to, major depressive disorder, bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder, premenstrual dysphoric disorder, and generalized anxiety disorder, which is in poor control and the primary focus of treatment.
- A diagnosis of social anxiety disorder with a score >60 on the Liebowitz Social Anxiety Scale.
- Subjects who meet criteria for moderate or severe alcohol or substance use disorder within the 1 year prior to Study entry.
- 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 considered to be an imminent danger to themselves or others.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PH94BAlso: AloradineIntranasal administration of 100 microliters to each nostril 4 times a day | Drug | PH94B |
| PlaceboIntranasal administration of 100 microliters to each nostril 4 times a day. | Drug | Placebo |
Primary outcome
Hamilton Anxiety Scale (HAM-A) Score
Time frame: 28 days
Least squares mean change from baseline to Visit 6 in anxiety level as measured by the HAM-A at the end of the 4-week treatment period. The HAM-A questionnaire consists of 14 items, each scored on a 5-point scale (0="Not present", 1="Mild", 2="Moderate", 3="Severe", 4="Very severe. The HAM-A total score is calculated as the sum of the 14 individual scores, ranging from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe. Higher total scores indicate more severe disease.
4 secondary outcomes
Percentage of Participants With Clinical Global Impression - Improvement Rating (CGI-I) Response
Time frame: 28 days
Percentage of Participants With Patient Global Impression of Change (PGI-C) Response
Time frame: 28 days
Adjustment Disorder New Module Scale (ADNM) Score
Time frame: 28 days
International Adjustment Disorder Questionnaire (IADQ) Score
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PH94B in people with Adjustment Disorder With Anxious Mood, run by VistaGen Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Scale (HAM-A) Score (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.