Phase 2
N=24
Effect of Ketamine on Laboratory-induced Stress in Healthy Subjects
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT04173962 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Change in The Profile of Mood States - Bipolar Version (POMS - Bi) Composed-Anxious Subscale — -6.8; -11.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ketamine (Drug); Midazolam (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in The Profile of Mood States - Bipolar Version (POMS - Bi) Composed-Anxious Subscale |
-6.8; -11.9 | — |
| SECONDARY Change in Salivary Cortisol |
0.1; 0.0 | — |
| SECONDARY Change in Systolic Blood Pressure |
4.3; 12.9 | — |
| SECONDARY Change in Diastolic Blood Pressure |
4.17; 6.58 | — |
| SECONDARY Change in Heart Rate |
-0.33; 3.83 | — |
| SECONDARY Change in Salivary Alpha-amylase Level |
109.0; 141.7 | — |
| SECONDARY Change in Positive and Negative Affect Scale (PANAS) |
2.2; 4.6; -2.2; 1.2 | — |
| SECONDARY Change in Visual Analog Scale: Stressed (VAS-Stressed) |
12.8; 12.1 | — |
| SECONDARY Change in Beck Anxiety Inventory (BAI) |
0.8; 2.6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04173962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.