NCT01217788

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

Enrollment Period

3 years

First QC Date

September 30, 2010

Last Update Submit

May 9, 2011

Conditions

Social PhobiaSocial Anxiety Disorder

Keywords

Generalized Social PhobiaSocial Anxiety DisorderSocial PhobiaPhobic DisordersPhobias

Outcome Measures

Primary Outcomes (1)

  • Subjective Unit of Discomfort Scale

    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

    Once at the end of the intervention and again one week after intervention (follow-up)

Study Arms (2)

PH94B intranasal spray

EXPERIMENTAL
Drug: PH94B intranasal spray

Placebo intranasal spray

PLACEBO COMPARATOR
Drug: PH94B intranasal spray

Interventions

PH94B intranasal sprayDRUG

Comparison of PH94B single dose intranasal spray and Placebo single dose intranasal spray

PH94B intranasal sprayPlacebo intranasal spray

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Network

New York, New York, 10024, United States

Location

Related Publications (1)

  • 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.

    PMID: 24700254DERIVED

MeSH Terms

Conditions

Phobia, SocialPhobic Disorders

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Michael L Liebowitz, M.D.

    Medical Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 8, 2010

Study Start

February 1, 2008

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

May 10, 2011

Record last verified: 2011-05

Locations

US(1)