CompletedPhase 2ketamine

Effect of Ketamine on Laboratory-induced Stress in Healthy Subjects

Sponsored by Icahn School of Medicine at Mount Sinai

NCT ID
NCT04173962
Target Enrollment
24 participants
Start Date
2019-08-08
Est. Completion
2021-03-18

About This Study

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.

Conditions Studied

Healthy Volunteers

Interventions

  • Ketamine
  • Midazolam

Eligibility

Age:18 Years - 45 Years
Healthy Volunteers:Yes
View full eligibility 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.

Study Locations (1)

Icahn School of Medicine at Mount Sinai
New York, New York, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source