A Study of the Efficacy of Botox in the Treatment of Social Anxiety Disorder

NCT03078270 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 041641
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to see whether Botox is an effective treatment for social anxiety disorder (SAD). Participants will complete two short surveys on depression and anxiety symptoms, receive a one-time injection of Botox, and complete the depression and anxiety survey 4 weeks after injection and again at 8 weeks after injection.

Conditions

Anxiety Disorder Social; Anxiety

Keywords

social anxiety; botulinum toxin; botox

Outcome Measures

Primary Outcomes (1)

• Efficacy of of Botulinum Toxin A Reducing Symptoms of Social Anxiety Disorder

  Repeated measure at baseline, 4-weeks and 8-weeks post-injection of anxiety using the Liebowitz Social Anxiety Scale to determine treatment response.

  2 months

Study Arms (2)

Open-label

OTHER

10 participants will be recruited for an open-label study. All will receive the active medication and complete depression and anxiety surveys at baseline, 4-weeks, and 8-weeks post injection. All participants will receive botulinum toxin A.

Drug: botulinum toxin A

Double-Blind

PLACEBO COMPARATOR

30 participants will be recruited for a double-blind, comparison study. Participants will be randomized to the active or control groups. Each will receive an injection (active medication or placebo) and will complete a depression and anxiety survey at baseline, 4-weeks and 8-weeks post injection. Participants in the active group will receive botulinum toxin A; participants in the control group will receive a placebo.

Drug: botulinum toxin A; Other: Placebo

Interventions

botulinum toxin A DRUG

Single treatment visit for 5 injections of botulinum toxin A, 40 units (for females) and 50 units (for males)/

Also known as: Botox

Double-Blind; Open-label

Placebo OTHER

single treatment visit for 5 injections of normal saline

Also known as: Saline

Double-Blind

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary diagnosis of social anxiety disorder
• women of childbearing potential on an acceptable form of birth control and are not pregnant or lactating

You may not qualify if:

• has ever been treated with botulinum toxin A
• has another Axis I diagnosis within in the 6-months prior to screening
• history of substance abuse within 2-months of screening
• current or recent suicidality
• scoring greater than 2 on Beck Depression Inventory (BDI) suicidality question
• psychotic or bipolar disorder
• unstable medical condition
• changes in medication or psychotherapy treatment in the month prior to screening
• significant risk of committing homicide

Sponsors & Collaborators

• Daniel Lieberman: lead

Study Sites (1)

GW University Medical Faculty Associated

Washington D.C., District of Columbia, 20036, United States

Location

Related Publications (5)

• Reichenberg JS, Hauptman AJ, Robertson HT, Finzi E, Kruger TH, Wollmer MA, Magid M. Botulinum toxin for depression: Does patient appearance matter? J Am Acad Dermatol. 2016 Jan;74(1):171-173.e1. doi: 10.1016/j.jaad.2015.08.051. No abstract available.

  PMID: 26702796 BACKGROUND

• Finzi E, Wasserman E. Treatment of depression with botulinum toxin A: a case series. Dermatol Surg. 2006 May;32(5):645-9; discussion 649-50. doi: 10.1111/j.1524-4725.2006.32136.x.

  PMID: 16706759 BACKGROUND

• Finzi E, Rosenthal NE. Emotional proprioception: Treatment of depression with afferent facial feedback. J Psychiatr Res. 2016 Sep;80:93-96. doi: 10.1016/j.jpsychires.2016.06.009. Epub 2016 Jun 16.

  PMID: 27344227 BACKGROUND

• Magid M, Reichenberg JS, Poth PE, Robertson HT, LaViolette AK, Kruger TH, Wollmer MA. Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014 Aug;75(8):837-44. doi: 10.4088/JCP.13m08845.

  PMID: 24910934 BACKGROUND

• Wollmer MA, de Boer C, Kalak N, Beck J, Gotz T, Schmidt T, Hodzic M, Bayer U, Kollmann T, Kollewe K, Sonmez D, Duntsch K, Haug MD, Schedlowski M, Hatzinger M, Dressler D, Brand S, Holsboer-Trachsler E, Kruger TH. Facing depression with botulinum toxin: a randomized controlled trial. J Psychiatr Res. 2012 May;46(5):574-81. doi: 10.1016/j.jpsychires.2012.01.027. Epub 2012 Feb 24.

  PMID: 22364892 BACKGROUND

MeSH Terms

Conditions

Phobia, Social; Anxiety Disorders

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Daniel Lieberman, M.D.
• Organization: George Washington University

dlieberman@mfa.gwu.edu

202-741-2899

Study Officials

• Daniel Z Lieberman, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician Faculty Director

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 13, 2017
• Study Start: February 1, 2017
• Primary Completion: September 12, 2017
• Study Completion: September 12, 2017
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)