Effect of Ketamine on Laboratory-induced Stress in Healthy Subjects

• Status: Completed
• Trial end date: 2021-03-18
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to examine the effect of a single IV dose of ketamine (0.5 mg/kg) on laboratory-induced stress in healthy participants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Ketamine; Midazolam

Criteria

Inclusion Criteria:

• Males and females aged 18-45 years;

• Does not meet for any current or past psychiatric diagnoses as defined by DSM-V criteria;

• Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.

Exclusion Criteria:

• Any current or lifetime psychiatric disorder as determined by the Structured Clinical Interview for DSM-V Axis Disorders (SCID-5);

• Concomitant use of any medication with central nervous system activity, including treatment with antidepressants (classified as SSRIs, SNRIs, Atypical Antidepressants, TCAs);

• Any unstable medical illnesses including hepatic, renal impairment, gastroenterologic (including gastro-esophageal reflux disease), respiratory (including obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics), cardiovascular (including ischemic heart disease and uncontrolled hypertension), endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;

• Hypertension (systolic BP >160 mm Hg or diastolic BP >90 mm Hg) at screening or immediately prior to treatment with ketamine/midazolam;

• Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG; clinically significant is defined by an abnormality that suggests a disease and/or organ toxicity that is new or has worsened from screening, or if the abnormality is of a degree that requires additional active management (e.g., further diagnostic investigation).

• Patients who have a positive urine toxicology test for illicit substances at screening and on the treatment day.

• Previous recreational use of PCP or ketamine.

• Subjects who have received ketamine in the past.