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NCT05320120

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

Completed Phase 1 Last updated 15 April 2024
What this trial tests

Phase 1 trial testing 56mg esketamine (2x Spravato® 28 mg nasal spray) in Ketamine Treatment in 33 participants. Completed in 21 June 2023.

Timeline
1 June 2022
Primary endpoint
21 June 2023
21 June 2023

Quick facts

Lead sponsorRupert Lanzenberger
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposebasic science
Enrollment33
Start date1 June 2022
Primary completion21 June 2023
Estimated completion21 June 2023
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Rupert Lanzenberger — full company profile →

Who can join

Adults 18 to 55, any sex, with Ketamine Treatment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Sex, drugs, and arousal-two randomized trials on the effects of ketamine on sexual arousal and calcarine gyrus activity.
    Klöbl M, Liebe T, Dörl G, Stöhrmann P, et al · · 2026 · PMID 41693798 · DOI 10.1177/20451253251406059

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