Skip to main content
OpenTrials
Completed

NCT Number: NCT05320120

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Psychiatry and Psychotherapy

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Drug

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

0.9% saline solution nasal spray

Drug

0.9% saline solution nasal spray

Primary outcomes

  1. BOLD response assessed with fMRI to arousal task

    Time frame: up to two weeks

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

Sponsors and collaborators

Lead sponsor

Rupert Lanzenberger

Other

Registry information

Official study title

Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI: a Placebo Controlled, Randomized, Cross-over Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2022
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.