Ketamine Infusion for Social Anxiety Disorder

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-02

Study Completion Date

2016-09-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ketamine Infusion for Obsessive-Compulsive Disorder

NCT01349231

Obsessive-compulsive Disorder

COMPLETED PHASE2

A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder

NCT02432703

Phobic Disorders

COMPLETED PHASE2

Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome

NCT00114127

Anxiety Disorder

COMPLETED PHASE3

Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety

NCT05683223

Social Anxiety Disorder

RECRUITING NA

Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)

NCT01100255

Obsessive-Compulsive Disorder

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Roughly one-third to one-half of patients with generalized SAD do not experience significant clinical benefit from current evidence-based treatment for SAD such as pharmacotherapy with selective serotonin reuptake inhibitors (SSRI) or venlafaxine and cognitive behavioral therapy (CBT). Failure of anxiety relief in patients with SAD is a source of substantial morbidity, distress, and decreases in quality of life. Novel pharmacological treatments are needed to improve patient outcomes with SAD.

Converging lines of evidence from neuroimaging and pharmacological studies support the importance of glutamate abnormalities in the pathogenesis of SAD. In a Magnetic Resonance Spectroscopy (MRS) study, an elevated glutamate to creatinine ratio was found in the anterior cingulate cortex of SAD patients when compared to healthy controls. Elevated thalamic glutamine levels have been demonstrated in patients with SAD. Pre-clinical rodent studies have also established a strong link between glutamate regulation and anxiety.

Ketamine is a potent antagonist of the N-methyl-D-aspartate (NMDA) receptor, a major type of glutamate receptor in the brain. Ketamine is routinely used for anesthetic induction because of its dissociative properties. However in research studies, ketamine is effective treatment in reducing symptoms in depressive and possibly anxiety disorders. In multiple controlled clinical studies, ketamine has produced a rapid antidepressant effect in unipolar and bipolar depression. Ketamine's anti-depressant effects peak 1-3 days following infusion. Ketamine's antidepressant effect is observed long after ketamine has been metabolized and excreted by the body and after ketamine's sedative and dissociative effects have dissipated.

The results of several clinical studies suggest that ketamine may also have significant anxiolytic effects. Patients with major depressive disorder given a single ketamine infusion have shown strong and significant reductions in comorbid anxiety symptoms. A trial including 11 depressed patients demonstrated a significant reduction in anxiety symptoms (Hamilton Anxiety Rating Scale (HAM-A)) following ketamine infusion. This improvement is supported by one of the earlier placebo-controlled trials of ketamine which demonstrated that the psychic anxiety item was one of 4 (out of 21) items on the Hamilton Depression Rating Scale (HAM-D) demonstrating significant improvement after ketamine infusion.

The investigators goal is to conduct a randomized, placebo-controlled crossover study to explore the efficacy and time course of action of intravenous ketamine in the treatment of SAD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Social Anxiety Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketamine infusion

A ketamine infusion was given on day 0 (28) at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1 (1+28), 2 (2+28), 3 (3+28), 5 (5+28), 7 (7+28), 10 (10+28) and 14 (14+28) post-infusion.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Ketamine (a single 0.5mg/kg intravenously over 40 minutes).

Saline infusion

A saline infusion was given on day 0 (28) at a dose of 0.5mg/kg over 40 minutes. Assessments were conducted pre-infusion, 3-h post-infusion, and days 1 (1+28), 2 (2+28), 3 (3+28), 5 (5+28), 7 (7+28), 10 (10+28) and 14 (14+28) post-infusion.

Group Type EXPERIMENTAL

Saline

Intervention Type OTHER

Saline (a single 0.5mg/kg intravenously over 40 minutes).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketamine

Ketamine (a single 0.5mg/kg intravenously over 40 minutes).

Intervention Type DRUG

Saline

Saline (a single 0.5mg/kg intravenously over 40 minutes).

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ketalar Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No