NCT02083926

Ketamine Infusion for Social Anxiety Disorder

Completed EARLY_PHASE1 Results posted Last updated 18 March 2021

What this trial tests

EARLY_PHASE1 trial testing Ketamine in Social Anxiety Disorder in 18 participants. Completed in 27 September 2016.

Timeline

2 January 2015

Primary endpoint
27 September 2016

27 September 2016

Quick facts

Lead sponsor	Yale University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	18
Start date	2 January 2015
Primary completion	27 September 2016
Estimated completion	27 September 2016
Sites	1 location across United States

Drugs / interventions tested

• Ketamine (ketamine) — full drug profile →
• Saline

Conditions studied

• Social Anxiety Disorder — all drugs for Social Anxiety Disorder →

Sponsor

Yale University

Who can join

Adults 18 to 65, any sex, with Social Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Analogue Scale for Anxiety Symptoms (VAS-anxiety) Primary · Day 1 (1+28)

Instrument that tries to measure anxiety, that is believed to range across a continuum of values and cannot easily be directly measured.We used a straight horizontal line of 100 mm in length. The ends were defined as the extreme limits of the parameter to be measured (anxiety); oriented from the left (no anxiety) to the right (worst anxiety ever felt). The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. We examine

Group	Value	95% CI
Ketamine Infusion on Day 0 or Day 28	12.1	± 18.6
Saline Infusion on Day 0 or Day 28	19.6	± 18.5

Liebowitz Social Anxiety Score (LSAS) Primary · Day 1 (1+28)

Clinician-administered scale for the assessment of fear and avoidance found in social phobia (SAD); it has 24 items divided into 2 subscales, 13 for performance anxiety, and 11 for social situations each rated from 0 to 3 (0=none,1=mild,2=moderate,3=definite). The sum scores for Fear and Avoidance results in an overall score (max 144 points). There are 4 clinician subscales: fear of social interaction, fear of performance, avoidance of social interaction and avoidance of performance 0 to 30= SAD is unlikely 30 to 60=SAD is probable 60 to 90=SADis very probable \>90= SAD highly probable

Group	Value	95% CI
Ketamine Infusion on Day 0 or Day 28	66.1	± 30.9
Saline Infusion on Day 0 or Day 28	86.1	± 30

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 hour after infusion. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ketamine Infusion on Day 0 or Day 28

Serious: 0/18 (0%)

Deaths: 0/18

Saline Infusion on Day 0 or Day 28

Serious: 0/17 (0%)

Deaths: 0/17

Other adverse events (27 terms — click to expand)

Reaction	System	Ketamine Infusion on Day 0…	Saline Infusion on Day 0 o…
Spaced out	Nervous system disorders	—	—
things seem unreal	Nervous system disorders	—	—
parestesias and numbness	Nervous system disorders	—	—
gaps in your memory	Nervous system disorders	—	—
things seem to be moving	Nervous system disorders	—	—
Feel like a spectator	Nervous system disorders	—	—
Things you can't account for	Nervous system disorders	—	—
dizziness	Nervous system disorders	—	—
Feel disconnected from your own body	Nervous system disorders	—	—
Feel as if you were in a tunnel	Nervous system disorders	—	—
Sounds almost disappear	Nervous system disorders	—	—
looking at things outside of your body	Nervous system disorders	—	—
Sense of your own body feel changed	Nervous system disorders	—	—
Outside of your body	Nervous system disorders	—	—
Tachycardia	Cardiac disorders	—	—
feel like you are separated from reality	Nervous system disorders	—	—
Objects look different	Nervous system disorders	—	—
things seem to be very real	Nervous system disorders	—	—
diastolyc hypertension	Cardiac disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Confused about who you really are	Nervous system disorders	—	—
systolic hypertension	Cardiac disorders	—	—
diastolyc hypotension	Cardiac disorders	—	—
Things happening very quickly	Nervous system disorders	—	—
Colors seem brighter	Nervous system disorders	—	—
Parts of your body that don't fit together	Nervous system disorders	—	—
having more than one identity	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT02083926 adverse events section.

Sponsor's own description

* 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ketamine for Social Anxiety Disorder: A Randomized, Placebo-Controlled Crossover Trial.
   Taylor JH, Landeros-Weisenberger A, Coughlin C, Mulqueen J, et al · · 2018 · cited 87× · PMID 28849779 · DOI 10.1038/npp.2017.194
2. Pharmacotherapy for social anxiety disorder (SAnD).
   Williams T, Hattingh CJ, Kariuki CM, Tromp SA, et al · · 2017 · cited 37× · PMID 29048739 · DOI 10.1002/14651858.cd001206.pub3
3. The effect of ketamine on cognition, anxiety, and social functioning in adults with psychiatric disorders: A systematic review and meta-analysis.
   Marchi M, Magarini FM, Galli G, Mordenti F, et al · · 2022 · cited 9× · PMID 36507365 · DOI 10.3389/fnins.2022.1011103