Social Anxiety DisorderPhase 3NCT02622958
Feasibility Study of PH94B Nasal Spray for Acute Treatment of Social Anxiety Disorder (SAD)
A Phase 3 study testing PH94B in people with Social Anxiety Disorder, run by Pherin Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to determine whether the PH94B nasal spray is effective for Acute Treatment of the symptoms of Social Anxiety Disorder (SAD) in adult men and women. The hypothesis is that PH94B nasal spray (.8 micrograms) has a rapid onset of efficacy to improve performance and interaction anxiety in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- PH94B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Social Anxiety Disorder as defined in the DSM IV of Mental Disorders, which is not secondary to another pre-existing psychiatric condition or to a medical condition.
- Confirmation of diagnosis of Social Anxiety Disorder according to the MINI, 5.0.0
- Clinician-rated Liebowitz Social Anxiety Scale total score ≥60 at both Screening and Baseline visits.
- Clinician-rated HAM-D17 total score <18 at both Screening and Baseline visits.
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- CGI-Severity score ≥4 at both Screening and Baseline visits.
- Subject must have:
- experienced and documented a minimum total of six social interaction or performance events during the two week Screening Period prior to the Baseline Visit, and
- for at least three of these events, must have achieved a peak score of ≥60 on the Subjective Units of Distress Scales (SUDS), as rated in the Patient Diary.
- 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 have a negative urine pregnancy test result prior to study medication administration.
Who cannot join
- History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, eating disorder, obsessive-compulsive disorder. Any other current Axis I disorder other than SAD which is the primary focus of treatment. Note that subjects with concurrent Generalized Anxiety Disorder (GAD) are eligible for the study provided that GAD is not the primary diagnosis.
- Subjects who meet criteria for substance abuse within the year prior to entry.
- Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, or nasal-septal perforation that may have damaged the nasal chemosensory epithelium.
- 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.
- Two or more documented failed treatment trials with a registered medication approved for SAD during the previous six months, whereby a treatment trial is defined as a period of at least six (6) weeks (or longer as documented in package insert for a particular drug) during which the patient received an adequate dosage (defined as the treatment dose indicated in the package insert to obtain efficacy for that particular drug) of the medication.
- Use of any psychotropic medication within 30 days prior to study entry (other than eszopiclone, ramelteon, zaleplon, or zolpidem for insomnia as described in Section 3.3).
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- Concomitant use of non-study anxiolytics such as benzodiazepines or beta blockers during the study and within 30 days prior to study entry.
- Concomitant use of any over-the-counter, prescription product, or herbal preparation for treatment of the symptoms of social anxiety during the study and within 30 days prior to study entry.
- Prior exposure to PH94B.
- Improvement of more than 20% in the LSAS score at Baseline relative to Screening.
- Women who have a positive urine human chorionic gonadotropin pregnancy test prior to study medication administration.
- Subjects with clinically significant abnormalities in hematology, blood chemistry, urinalysis, ECG, or physical examination identified at the Screening or Baseline visit.
- Subjects with a positive urine drug screen at either the Screening or Baseline visit.
- Presence of any clinical condition or disease, or use of a concomitant medication, that in the clinical judgment of the Investigator could place the patient at undue risk, interfere with study participation, or confound the results of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical Research Network, LLC
New York, New York, 10128
About this study
Official title: A Feasibility Study for a Phase 3, Randomized, Four-Week, Double-Blind, Placebo-Controlled, Crossover Trial of the Efficacy and Safety of PH94B Nasal Spray in the Acute Treatment of Social Anxiety Disorder (SAD)
The purpose of the study is to determine whether the PH94B nasal spray is effective for Acute Treatment of the symptoms of Social Anxiety Disorder (SAD) in adult men and women. The hypothesis is that PH94B nasal spray (.8 micrograms) has a rapid onset of efficacy to improve performance and interaction anxiety in patients with diagnosed Social Anxiety Disorder (SAD).
Read the detailed description
The study is a randomized, double-blind, placebo-controlled, 2-way crossover trial of the efficacy and safety of PH94B in the treatment of subjects diagnosed with Social Anxiety Disorder as defined by the Diagnostic and Statistical Manual IV and confirmed by the MINI (5.0.0). The study is intended to serve as a feasibility trial of a multi-center phase 3 study protocol of similar design.
The primary objective of this study is to evaluate design features for a larger Phase 3 study that will evaluate the safety and efficacy of PH94B for the acute management of symptoms in subjects with Social Anxiety Disorder. Careful review of diary entries and measurement of study medication compliance each week will be used to determine the feasibility of using the study medication on an "as needed" basis for anxiety-provoking social events. Specifically, the frequency of use, variability of SUDS ratings, effect size of differences in average peak SUDS ratings during treatment with PH94B and placebo, and general reliability of the diary recording method will be evaluated and used to refine inclusion and exclusion criteria as well as provide guidance for designing a larger multi-site study.
The study will last a total of 6-8 weeks. The randomized double-blind treatment period will last a total of four weeks for all subjects.
- Conditions
- Social Anxiety Disorder
- Being tested
- PH94B, Placebo
- Keywords
- Social Anxiety Disorder, Social Phobia, Performance Anxiety, Social Anxiety, Anxiety
- Medical subject headings
- Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH94BDrug
PH94B is self-administered intranasally as needed or as necessary, no more than four doses per day for male and female subjects. Each spray delivers 50 µL (0.8 µg PH94B).
Dosing is sex-specific:
- Males: two (2) sprays (100 µL) are to be administered to each nostril, for a total dose of 3.2 µg
- Females: one (1) spray (50 µL) is to be administered to each nostril, for a total dose of 1.6 µg
PlaceboOther
Placebo is self-administered intranasally as needed or as necessary, no more than four doses per day for male and female subjects. Each spray delivers 50 µL (0.8 µg Placebo).
Dosing is sex-specific:
- Males: two (2) sprays (100 µL) are to be administered to each nostril, for a total dose of 3.2 µg
- Females: one (1) spray (50 µL) is to be administered to each nostril, for a total dose of 1.6 µg
| Study group | Role | What they receive |
|---|---|---|
| PH94B Nasal Spray | Experimental | Water based solution of 16 ppm PH94B. Each nasal spray delivers .8 micrograms PH94B in 50 microliters Receives: Drug: PH94B |
| Placebo Nasal Spray | Placebo comparator | Water based solution, each nasal spray delivers 50 microliters of droplets. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective units of distress
The primary study endpoint is average peak anxiety level for public performance or social interaction events during the two 2-week double-blind treatment phases (PH94B and placebo). Subjects will be asked to self-administer double-blind PH94B or placebo 15 minutes prior to public performance or social interaction events. Following each event, they will be asked to record the maximum (peak) subjective anxiety level experienced during the event using the patient rated Subjective Units of Distress Scale (SUDS), where anxiety scores range from 0 (no anxiety) to 100 (maximum anxiety ever experienced). Within each 2-week treatment phase, all subjective anxiety ratings will be summed and divided by the number of events recorded.
Measured: Study medication nasal spray is to be administered 15 minutes prior to public performance and following each event they will be asked to record maximum subjective anxiety level experienced during the event.
Secondary outcomes (1)
Clinical Global Impression of Improvement rating & Liebowitz Social Anxiety Scale
Two key secondary endpoints of the study are overall subject improvement as assessed by the Clinical Global Impression of Improvement rating (CGI-I), and the Investigator rated Liebowitz Social Anxiety Scale (LSAS). The proportion of subjects receiving a clinician-rated CGI-I score of 1 (Very much improved) or 2 (Much improved) following two weeks of treatment with placebo will be compared to the proportion of patients receiving a clinician-rated CGI-I score of 1 or 2 following two weeks of treatment with PH94B.
Measured: At baseline and following 2 weeks of treatment with Study medication nasal spray
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pherin Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Liebowitz, Principal investigator, The Medical Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622958
- Sponsor's protocol ID
- PH94B CL028
- Status last verified
- Dec 2015
- First submitted
- 18 Mar 2014
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Liebowitz MR, Hanover R, Draine A, Lemming R, Careri J, Monti L. Effect of as-needed use of intranasal PH94B on social and performance anxiety in individuals with social anxiety disorder. Depress Anxiety. 2016 Dec;33(12):1081-1089. doi: 10.1002/da.22546. Epub 2016 Aug 25.
PubMed 27561175
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for a Phase 3, Randomized, Four-Week, Double-Blind, Placebo-Controlled, Crossover Trial of the Efficacy and Safety of PH94B Nasal Spray in the Acute Treatment of Social Anxiety Disorder (SAD)
- ClinicalTrials.gov ID
- NCT02622958
- Acronym / sponsor ID
- PH94B CL028
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety Disorder, Social Phobia, Performance Anxiety, Social Anxiety, Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Pherin Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether the PH94B nasal spray is effective for Acute Treatment of the symptoms of Social Anxiety Disorder (SAD) in adult men and women. The hypothesis is that PH94B nasal spray (.8 micrograms) has a rapid onset of efficacy to improve performance and interaction anxiety in patients with diagnosed Social Anxiety Disorder (SAD).
Detailed description
The study is a randomized, double-blind, placebo-controlled, 2-way crossover trial of the efficacy and safety of PH94B in the treatment of subjects diagnosed with Social Anxiety Disorder as defined by the Diagnostic and Statistical Manual IV and confirmed by the MINI (5.0.0). The study is intended to serve as a feasibility trial of a multi-center phase 3 study protocol of similar design.
The primary objective of this study is to evaluate design features for a larger Phase 3 study that will evaluate the safety and efficacy of PH94B for the acute management of symptoms in subjects with Social Anxiety Disorder. Careful review of diary entries and measurement of study medication compliance each week will be used to determine the feasibility of using the study medication on an "as needed" basis for anxiety-provoking social events. Specifically, the frequency of use, variability of SUDS ratings, effect size of differences in average peak SUDS ratings during treatment with PH94B and placebo, and general reliability of the diary recording method will be evaluated and used to refine inclusion and exclusion criteria as well as provide guidance for designing a larger multi-site study.
The study will last a total of 6-8 weeks. The randomized double-blind treatment period will last a total of four weeks for all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PH94B Nasal Spray | Experimental | Drug: PH94BWater based solution of 16 ppm PH94B. Each nasal spray delivers .8 micrograms PH94B in 50 microliters |
| Placebo Nasal Spray | Placebo comparator | Other: PlaceboWater based solution, each nasal spray delivers 50 microliters of droplets. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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 Social Anxiety Disorder as defined in the DSM IV of Mental Disorders, which is not secondary to another pre-existing psychiatric condition or to a medical condition.
- Confirmation of diagnosis of Social Anxiety Disorder according to the MINI, 5.0.0
- Clinician-rated Liebowitz Social Anxiety Scale total score ≥60 at both Screening and Baseline visits.
Key exclusion criteria (14 listed)
- History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, eating disorder, obsessive-compulsive disorder. Any other current Axis I disorder other than SAD which is the primary focus of treatment. Note that subjects with concurrent Generalized Anxiety Disorder (GAD) are eligible for the study provided that GAD is not the primary diagnosis.
- Subjects who meet criteria for substance abuse within the year prior to entry.
- Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, or nasal-septal perforation that may have damaged the nasal chemosensory epithelium.
- 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.
- Two or more documented failed treatment trials with a registered medication approved for SAD during the previous six months, whereby a treatment trial is defined as a period of at least six (6) weeks (or longer as documented in package insert for a particular drug) during which the patient received an adequate dosage (defined as the treatment dose indicated in the package insert to obtain efficacy for that particular drug) of the medication.
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 |
|---|---|---|
| PH94BPH94B is self-administered intranasally as needed or as necessary, no more than four doses per day for male and female subjects. Each spray delivers 50 µL (0.8 µg PH94B). Dosing is sex-specific: * Males: two (2) sprays (100 µL) are to be administered to each nostril, for a total dose of 3.2 µg * Females: one (1) spray (50 µL) is to be administered to each nostril, for a total dose of 1.6 µg | Drug | PH94B Nasal Spray |
| PlaceboPlacebo is self-administered intranasally as needed or as necessary, no more than four doses per day for male and female subjects. Each spray delivers 50 µL (0.8 µg Placebo). Dosing is sex-specific: * Males: two (2) sprays (100 µL) are to be administered to each nostril, for a total dose of 3.2 µg * Females: one (1) spray (50 µL) is to be administered to each nostril, for a total dose of 1.6 µg | Other | Placebo Nasal Spray |
Primary outcome
Subjective units of distress
Time frame: Study medication nasal spray is to be administered 15 minutes prior to public performance and following each event they will be asked to record maximum subjective anxiety level experienced during the event.
The primary study endpoint is average peak anxiety level for public performance or social interaction events during the two 2-week double-blind treatment phases (PH94B and placebo). Subjects will be asked to self-administer double-blind PH94B or placebo 15 minutes prior to public performance or social interaction events. Following each event, they will be asked to record the maximum (peak) subjective anxiety level experienced during the event using the patient rated Subjective Units of Distress Scale (SUDS), where anxiety scores range from 0 (no anxiety) to 100 (maximum anxiety ever experienced). Within each 2-week treatment phase, all subjective anxiety ratings will be summed and divided by the number of events recorded.
1 secondary outcome
Clinical Global Impression of Improvement rating & Liebowitz Social Anxiety Scale
Time frame: At baseline and following 2 weeks of treatment with Study medication nasal spray
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
- Derived from this study: PubMed 27561175Liebowitz MR, Hanover R, Draine A, Lemming R, Careri J, Monti L. Effect of as-needed use of intranasal PH94B on social and performance anxiety in individuals with social anxiety disorder. Depress Anxiety. 2016 Dec;33(12):1081-1089. doi: 10.1002/da.22546. Epub 2016 Aug 25.
- Related InfoLink provided by the sponsor.
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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.
Michael Liebowitz principal investigator
The Medical Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PH94B in people with Social Anxiety Disorder, run by Pherin Pharmaceuticals, Inc. at 1 site 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 11 inclusion and 14 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 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjective units of distress (time frame: Study medication nasal spray is to be administered 15 minutes prior to public performance and following each event they will be asked to record maximum subjective anxiety level experienced during the event.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02622958, which also lists 1 linked publication.
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 7 Dec 2015.