Change from pre- to post-TSST in The Profile of Mood States - Bipolar Version (POMS - Bi) scale measures moods and feelings primarily in clinical rather than nonclinical settings. The POMS-Bi consists of 72 adjectives that form six bipolar sub-scale scores (Composed - Anxious, Clear - Confused, Confident - Unsure, Agreeable - Hostile, Energetic - Tired, Elated - Depressed). Each of the 12 adjectives within each subscale is rated on a 4-point Likert scale with anchors of 0 = "much unlike this," 1 = "slightly unlike this," 2 = "slightly like this," and 3 = "much like this." The Composed-Anxious Subscale score is the sum of positive minus the sum of negative responses plus a constant of 18. The subscale score range is from 0 to 36. Higher score indicates higher functioning. Each subscale is separate and there is no overall score.
Effect of Ketamine on Laboratory-induced Stress in Healthy Subjects
Brief Summary
Intervention / Treatment
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Ketamine (DRUG)administered 1 week prior to a laboratory-induced stress
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Midazolam (DRUG)administered 1 week prior to a laboratory-induced stress
Condition or Disease
- Healthy Volunteers
Phase
Study Design
| Study type: | INTERVENTIONAL |
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| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 45 Years |
| Enrollment: | 24 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Prevention |
MaskingMidazolam has similar acute anesthetic effects compared to ketamine. This makes midazolam an appropriate substance to gauge whether ketamine can affect stress response thereby acting as an active control. QUADRUPLE:
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Clinical Trial Dates
| Start date: | Aug 08, 2019 | ACTUAL |
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| Primary Completion: | Mar 18, 2021 | ACTUAL |
| Completion Date: | Mar 18, 2021 | ACTUAL |
| Study First Posted: | Nov 22, 2019 | ACTUAL |
| Results First Posted: | May 10, 2022 | ACTUAL |
| Last Updated: | Apr 18, 2022 |
Sponsors / Collaborators
Location
Participant Groups
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One 0.5mg/kg intravenous dose of ketamine
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One 0.045mg/kg intravenous dose of midazolam
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 45 |
| Age Groups: | Adult |
| Healthy Volunteers: | Yes |
* 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.
Primary Outcomes
Secondary Outcomes
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Change from pre- to post-TSST in salivary cortisol level. Salivary cortisol level to assess effect on the hypothalamic-pituitary-adrenal axis (HPA axis).
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Change from pre- to post-TSST in Cardiovascular response to stressor during assessment visit
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Change from pre- to post-TSST in Cardiovascular response to stressor during assessment visit
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Change from pre- to post-TSST in Cardiovascular response to stressor during assessment visit
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Change from pre- to post-TSST in Salivary alpha-amylase level to assess effect on the adrenaline-noradrenaline axis (ANS axis).
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Change from pre- to post-TSST in The Positive and Negative Affect Scale (PANAS) measures both positive and negative affect and is utilized within clinical and non-clinical populations. The PANAS is a 20-item instrument, each item is scored on a 5-likert scale from 1 (very slightly or not at all) to 5 (extremely). Positive Affect Score - total score from 10-50, with higher score indicating higher levels of positive affect. Negative Affect Score - total score from 10-50, with lower scores representing lower levels of negative affect.
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Change from pre- to post-TSST in The Visual Analog Scales are scored in millimeters from the left-hand side of a 100-mm line to a perpendicular mark made by the patient at a point corresponding to the apparent magnitude of the feeling state. Full range: 0 ("not at all") to 100 ("most ever"), with higher score indicating poorer health status. The VAS-Stressed prompts participants to rate their level of stress in that exact moment on the visual analog scale.
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Change from pre- to post-TSST in Beck Anxiety Inventory (BAI). This is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in adults. The questions used in this measure ask about common symptoms of anxiety (such as numbness and tingling, sweating not due to heat, and fear of the worst happening). It is designed for individuals who are of 17 years of age or older and takes 5 to 10 minutes to complete. Total score range of 0-63, with higher score indicating more severe anxiety symptoms.
More Details
| NCT Number: | NCT04173962 |
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| Other IDs: | GCO 17-2440 |
| Study URL: | https://clinicaltrials.gov/study/NCT04173962 |