Effect of Ketamine on Laboratory-induced Stress in Healthy Subjects

NCT04173962 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GCO 17-2440
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Ketamine; Resilience; Stress; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Change in The Profile of Mood States - Bipolar Version (POMS - Bi) Composed-Anxious Subscale

  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.

  baseline and 1 week after infusion

Secondary Outcomes (8)

• Change in Salivary Cortisol

  baseline and 1 week after infusion

• Change in Systolic Blood Pressure

  baseline and 1 week after infusion

• Change in Diastolic Blood Pressure

  baseline and 1 week after infusion

• Change in Heart Rate

  baseline and 1 week after infusion

• Change in Salivary Alpha-amylase Level

  baseline and 1 week after infusion

Study Arms (2)

Ketamine group

EXPERIMENTAL

One 0.5mg/kg intravenous dose of ketamine

Drug: Ketamine

Midazolam group

ACTIVE COMPARATOR

One 0.045mg/kg intravenous dose of midazolam

Drug: Midazolam

Interventions

Ketamine DRUG

administered 1 week prior to a laboratory-induced stress

Ketamine group

Midazolam DRUG

administered 1 week prior to a laboratory-induced stress

Midazolam group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (3)

• O'Halloran PD, Murphy GC, Webster KE. Reliability of the bipolar form of the profile of mood states using an alternative test protocol. Psychol Rep. 2004 Oct;95(2):459-63. doi: 10.2466/pr0.95.2.459-463.

  PMID: 15587208 BACKGROUND

• Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.

  PMID: 3204199 BACKGROUND

• Crawford JR, Henry JD. The positive and negative affect schedule (PANAS): construct validity, measurement properties and normative data in a large non-clinical sample. Br J Clin Psychol. 2004 Sep;43(Pt 3):245-65. doi: 10.1348/0144665031752934.

  PMID: 15333231 BACKGROUND

MeSH Terms

Interventions

Ketamine; Midazolam

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. James Murrough
• Organization: Icahn School of Medicine at Mount Sinai

james.murrough@mssm.edu

212-585-4640

Study Officials

• James Murrough, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Midazolam 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are assigned to one of two groups in parallel during the duration of the study: the ketamine arm or the midazolam arm.

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 22, 2019
• Study Start: August 8, 2019
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: May 10, 2022
• Results First Posted: May 10, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)