Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI

NCT05320120 | Completed Phase 1

• 1 other identifier: PSY-NIL-0011
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Subanesthetic ketamine is currently used as a rapid-acting antidepressant. It is an antagonist of the N-methyl-d-aspartate (NMDA) receptor, but former results indicate that its action also depends on the noradrenaline system and the locus coeruleus (LC). Based on this known impact of ketamine on the sympathetic nervous system the aim of this study is to investigate the effects of intranasal esketamine on LC related attentional brain networks in task based functional MRI, to relate those attention network changes to behavioural measures and to predict ketamine related attention network changes by brain structure.

Conditions

Ketamine Treatment

Outcome Measures

Primary Outcomes (1)

• BOLD response assessed with fMRI to arousal task

  Blood oxygen level (BOLD) response assessed with functional magnetic resonance imaging (fMRI) during an arousal task

  up to two weeks

Study Arms (2)

first 56mg esketamine (2x Spravato® 28 mg nasal spray), then placebo

EXPERIMENTAL

Drug: 56mg esketamine (2x Spravato® 28 mg nasal spray); Drug: 0.9% saline solution nasal spray

first placebo (0.9% saline solution nasal spray), then ketamine

EXPERIMENTAL

Drug: 56mg esketamine (2x Spravato® 28 mg nasal spray); Drug: 0.9% saline solution nasal spray

Interventions

56mg esketamine (2x Spravato® 28 mg nasal spray) DRUG

56mg esketamine (2x Spravato® 28 mg nasal spray)

first 56mg esketamine (2x Spravato® 28 mg nasal spray), then placebo; first placebo (0.9% saline solution nasal spray), then ketamine

0.9% saline solution nasal spray DRUG

0.9% saline solution nasal spray

first 56mg esketamine (2x Spravato® 28 mg nasal spray), then placebo; first placebo (0.9% saline solution nasal spray), then ketamine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• General health (no serious internal or neurologic pre-existing conditions) based on medical history, physical examination and structured clinical interview for DSM-IV (SCID)
• Age 18 to 55 years
• Right-handedness (due to potential lateralization effects of left-handed subjects)
• Willingness and competence to sign the informed consent form

You may not qualify if:

• Current or history of psychiatric or neurological disease
• Current medical illness requiring treatment
• Current or former substance abuse
• Pregnancy or current breastfeeding
• Diagnosis of an Axis-1 psychotic disorder in a first-degree relative
• Known aneurysmal vascular disease based on medical history (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels), history of intracerebral haemorrhage, recent (within 6weeks) cardiovascular event, including myocardial infarction (MI)
• Significant pulmonary insufficiency, including COPD; sleep apnoea with morbid obesity (BMI ≥35), uncontrolled brady- or tachyarrhythmias that lead to haemodynamic instability; history of an MI, haemodynamically significant valvular heart disease or heart failure (NYHA Class III-IV)
• Hyperthyroidism that has not been sufficiently treated
• History of brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure
• Child-Pugh class C (severe) hepatic impairment
• Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental implants causing signal artifacts
• Failure to comply with the study protocol or to follow the instruction of the investigating team

Sponsors & Collaborators

• Rupert Lanzenberger: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

Esketamine; Nasal Sprays

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Rupert Lanzenberger

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: April 11, 2022
• Study Start: June 1, 2022
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

AU (1)