Overview

Ketamine Infusion for Social Anxiety Disorder

Status:
Completed
Trial end date:
2016-09-27
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yale University
Collaborator:
Patterson Trust Awards Program in Clinical Research
Treatments:
Ketamine
Criteria
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)