Social PhobiaPhase 2PH94B-SADNCT01217788
Intranasal PH94B for Management of the Symptoms of Generalized Social Phobia
A Phase 2 study testing PH94B intranasal spray in people with Social Phobia and Social Anxiety Disorder, run by Pherin Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of PH94B, a new class of therapeutic compound, administered intranasally for the management of acute anxiety in patients diagnosed with generalized social phobia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Phobia, Social Anxiety Disorder
- What is being tested?
- PH94B intranasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Mar 2011
- Phase
- Phase 2
- 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
- Subject currently meets the Diagnosis of Social Phobia as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition which is not secondary to another pre-existing psychiatric condition or to a medical condition.
- Liebowitz Social Anxiety Scale (LSAS) score greater than or equal to 60 at Screening.
- Score of 75 or greater on the SUD scale at one of the Performance Phase time points during either the Public Speaking or Social Interaction Challenge
- Written Informed Consent prior to commencing any study specific procedures.
- Women of child-bearing-potential must be able to commit to the consistent and correct use of an acceptable method of birth control throughout the study and have a negative serum pregnancy test result prior to study drug administration.
Who cannot join
- Use of any psychotropic medication within 30 days prior to study entry.
- Acute or chronic psychiatric disease which is the primary diagnosis (except Social Phobia) at the time of the study. Note that subjects with concurrent Generalized Anxiety Disorder (GAD) are allowed into the study provided this is not the primary diagnosis.
- Subjects with a history of psychiatric diseases such as schizophrenia, bipolar disorder, and psychosis are to be excluded.
- Presence of a 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.
- Use of substances of abuse within the year 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 and use of non-study anxiolytics such as benzodiazepines during the study and within 30 days prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Placebo Controlled Study of PH94B for Management of the Symptoms of Generalized Social Phobia
The purpose of this study is to determine the efficacy of PH94B, a new class of therapeutic compound, administered intranasally for the management of acute anxiety in patients diagnosed with generalized social phobia.
Read the detailed description
The essential features of generalized social phobia are defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), criteria as a marked and persistent fear of most (generally accepted as four or more) social or performance situations in which the patient believes embarrassment could occur as a consequence of exposure to unfamiliar people and/or possible scrutiny by others. The anxiety resulting from the social or performance situation is profound. The avoidance, fear, or anxious anticipation of these situations interferes significantly with the person's daily routine, having a marked impact on occupational functioning and/or social life. The disorder has a lifetime prevalence estimated at up to 13%, with onset typically in the mid-teens, and it is diagnosed slightly more frequently in females than in males. Social phobia tends to be a chronic disorder with periods of exacerbation, with a reported mean duration of illness of approximately 20 years.
There are two subtypes of social phobia: (i) generalized (discrete), which is suffered by approximately 50% of social phobia patients and in which fear and avoidance extend to a wide range of social situations, and (ii) non-generalized, in which the patient fears only one or a few circumscribed situations. Speaking in front of large groups is by far the most prevalent of social fears (Lang and Stein, 2001).
Social phobia has a lifetime comorbidity rate of approximately 81% with other psychiatric disorders (particularly affective disorders, other anxiety disorders, and substance abuse disorders), as well as to being associated with increased nonpsychiatric medical difficulties. People with social phobia identify social impairment, inadequate social support, overall role impairment, specific impairment in education, work, and other activities, as well as interference in their efforts at self-improvement. Unfortunately, for these patients, there is a strong consensus that social phobia is one of the least commonly recognized and treated mental disorders
- Conditions
- Social Phobia, Social Anxiety Disorder
- Being tested
- PH94B intranasal spray
- Keywords
- Generalized Social Phobia, Social Anxiety Disorder, Social Phobia, Phobic Disorders, Phobias
- Medical subject headings
- Phobia, Social, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH94B intranasal sprayDrug
Comparison of PH94B single dose intranasal spray and Placebo single dose intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| PH94B intranasal spray | Experimental | Not described Receives: Drug: PH94B intranasal spray |
| Placebo intranasal spray | Placebo comparator | Not described Receives: Drug: PH94B intranasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Unit of Discomfort Scale
Measured: Once before and again 10 minutes after intranasal dosing with PH94B spray, during exposure to a public speaking challenge
Secondary outcomes (1)
Number of patients with adverse events as a measure of safety and tolerability on the psychometric scale
One time after dosing and up to one week after dosing.
Measured: Once at the end of the intervention and again one week after intervention (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startFeb 2008
- Primary completionFeb 2011
- Study completionMar 2011
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 PhobiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pherin Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael L Liebowitz, M.D., Principal investigator, Medical Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217788
- Sponsor's protocol ID
- PH94B CL022
- Acronym
- PH94B-SAD
- Status last verified
- May 2011
- First submitted
- 30 Sep 2010
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liebowitz MR, Salman E, Nicolini H, Rosenthal N, Hanover R, Monti L. Effect of an acute intranasal aerosol dose of PH94B on social and performance anxiety in women with social anxiety disorder. Am J Psychiatry. 2014 Jun;171(6):675-82. doi: 10.1176/appi.ajp.2014.12101342.
PubMed 24700254
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Placebo Controlled Study of PH94B for Management of the Symptoms of Generalized Social Phobia
- ClinicalTrials.gov ID
- NCT01217788
- Acronym / sponsor ID
- PH94B-SAD / PH94B CL022
- Conditions
- Social Phobia, Social Anxiety Disorder
- Keywords
- Generalized Social Phobia, Social Anxiety Disorder, Social Phobia, Phobic Disorders, Phobias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pherin Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 8 Oct 2010 (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 this study is to determine the efficacy of PH94B, a new class of therapeutic compound, administered intranasally for the management of acute anxiety in patients diagnosed with generalized social phobia.
Detailed description
The essential features of generalized social phobia are defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), criteria as a marked and persistent fear of most (generally accepted as four or more) social or performance situations in which the patient believes embarrassment could occur as a consequence of exposure to unfamiliar people and/or possible scrutiny by others. The anxiety resulting from the social or performance situation is profound. The avoidance, fear, or anxious anticipation of these situations interferes significantly with the person's daily routine, having a marked impact on occupational functioning and/or social life. The disorder has a lifetime prevalence estimated at up to 13%, with onset typically in the mid-teens, and it is diagnosed slightly more frequently in females than in males. Social phobia tends to be a chronic disorder with periods of exacerbation, with a reported mean duration of illness of approximately 20 years.
There are two subtypes of social phobia: (i) generalized (discrete), which is suffered by approximately 50% of social phobia patients and in which fear and avoidance extend to a wide range of social situations, and (ii) non-generalized, in which the patient fears only one or a few circumscribed situations. Speaking in front of large groups is by far the most prevalent of social fears (Lang and Stein, 2001).
Social phobia has a lifetime comorbidity rate of approximately 81% with other psychiatric disorders (particularly affective disorders, other anxiety disorders, and substance abuse disorders), as well as to being associated with increased nonpsychiatric medical difficulties. People with social phobia identify social impairment, inadequate social support, overall role impairment, specific impairment in education, work, and other activities, as well as interference in their efforts at self-improvement. Unfortunately, for these patients, there is a strong consensus that social phobia is one of the least commonly recognized and treated mental disorders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PH94B intranasal spray | Experimental | Drug: PH94B intranasal spray |
| Placebo intranasal spray | Placebo comparator | Drug: PH94B intranasal spray |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject currently meets the Diagnosis of Social Phobia as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition which is not secondary to another pre-existing psychiatric condition or to a medical condition.
- Liebowitz Social Anxiety Scale (LSAS) score greater than or equal to 60 at Screening.
- Score of 75 or greater on the SUD scale at one of the Performance Phase time points during either the Public Speaking or Social Interaction Challenge
- Written Informed Consent prior to commencing any study specific procedures.
- Women of child-bearing-potential must be able to commit to the consistent and correct use of an acceptable method of birth control throughout the study and have a negative serum pregnancy test result prior to study drug administration.
Key exclusion criteria (6 listed)
- Use of any psychotropic medication within 30 days prior to study entry.
- Acute or chronic psychiatric disease which is the primary diagnosis (except Social Phobia) at the time of the study. Note that subjects with concurrent Generalized Anxiety Disorder (GAD) are allowed into the study provided this is not the primary diagnosis.
- Subjects with a history of psychiatric diseases such as schizophrenia, bipolar disorder, and psychosis are to be excluded.
- Presence of a 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.
- Use of substances of abuse within the year prior to study entry.
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 |
|---|---|---|
| PH94B intranasal sprayComparison of PH94B single dose intranasal spray and Placebo single dose intranasal spray | Drug | PH94B intranasal spray, Placebo intranasal spray |
Primary outcome
Subjective Unit of Discomfort Scale
Time frame: Once before and again 10 minutes after intranasal dosing with PH94B spray, during exposure to a public speaking challenge
1 secondary outcome
Number of patients with adverse events as a measure of safety and tolerability on the psychometric scale
Time frame: Once at the end of the intervention and again one week after intervention (follow-up)
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 10 May 2011.
- Derived from this study: PubMed 24700254Liebowitz MR, Salman E, Nicolini H, Rosenthal N, Hanover R, Monti L. Effect of an acute intranasal aerosol dose of PH94B on social and performance anxiety in women with social anxiety disorder. Am J Psychiatry. 2014 Jun;171(6):675-82. doi: 10.1176/appi.ajp.2014.12101342.
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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 L Liebowitz, M.D. principal investigator
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 2 study testing PH94B intranasal spray in people with Social Phobia and 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 5 inclusion and 6 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 10 May 2011. 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 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?
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 Unit of Discomfort Scale (time frame: Once before and again 10 minutes after intranasal dosing with PH94B spray, during exposure to a public speaking challenge). 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 NCT01217788, 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 10 May 2011.