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CompletedEarly Phase 1Results posted

Ketamine Infusion for Social Anxiety Disorder

NCT02083926 · Yale University

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
18
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Visual Analogue Scale for Anxiety Symptoms (VAS-anxiety)

    Measured over Day 1 (1+28)

  • Liebowitz Social Anxiety Score (LSAS)

    Measured over Day 1 (1+28)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Adult between the ages of 18 and 65 years 2. 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: 1. Positive pregnancy test 2. History of substance abuse disorder within the last 6 months or positive urine toxicology on screening (within the previous 6 months). 3. History of pervasive developmental disorder or psychotic disorder by DSM-IV-TR criteria 4. Medical comorbidity that significantly increases the risks associated with ketamine infusion (e.g. untreated hypertension, significant cardiovascular disease)

Where

1 study site

FacilityCityRegionCountry
Connecticut Mental Health CenterNew HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02083926 on ClinicalTrials.gov →

Last updated in the registry 2021-03-18. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

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