Early Phase 1 N=18 Randomized Quadruple-blind Treatment

Ketamine Infusion for Social Anxiety Disorder

Social Anxiety Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02083926 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Visual Analogue Scale for Anxiety Symptoms (VAS-anxiety) — 12.1; 19.6 units on a scale

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Ketamine (Drug); Saline (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analogue Scale for Anxiety Symptoms (VAS-anxiety)	12.1; 19.6	—
PRIMARY Liebowitz Social Anxiety Score (LSAS)	66.1; 86.1	—

Summary

* Social Anxiety Disorder (SAD) is common and causes significant impairment. * First-line treatments for Social Anxiety Disorder are only partially effective. Many SAD patients experience little or inadequate symptom relief with available treatments. * Ketamine is a potent NMDA receptor antagonist. Ketamine represents an agent with a potentially novel mechanism of action for the treatment of anxiety disorders. * Ketamine has demonstrated efficacy in the treatment of psychiatric disorders closely related to Social Anxiety Disorder including Major Depression, Bipolar Depression and possibly Obsessive-Compulsive Disorder. Ketamine represents the possibility to provide rapid symptom relief to patients with SAD and may provide the mechanism for future drug development to treat SAD more rapidly and effectively.

Eligibility Criteria

Inclusion Criteria

Adult between the ages of 18 and 65 years
Meet DSM IV criteria for Social Anxiety Disorder by structured clinical interview (SCID) and have a LSAS >60 with or without co-morbid MDD

Exclusion Criteria

Positive pregnancy test
History of substance abuse disorder within the last 6 months or positive urine toxicology on screening (within the previous 6 months).
History of pervasive developmental disorder or psychotic disorder by DSM-IV-TR criteria
Medical comorbidity that significantly increases the risks associated with ketamine infusion (e.g. untreated hypertension, significant cardiovascular disease)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02083926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.