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

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ClinicalTrials.gov Identifier: NCT05320120
Recruitment Status : Not yet recruiting
First Posted : April 11, 2022
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE February 28, 2022
First Posted Date  ICMJE April 11, 2022
Last Update Posted Date April 11, 2022
Estimated Study Start Date  ICMJE April 23, 2022
Estimated Primary Completion Date April 22, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2022)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI
Official Title  ICMJE Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI: a Placebo Controlled, Randomized, Cross-over Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Condition  ICMJE Ketamine Treatment
Intervention  ICMJE
  • Drug: 56mg esketamine (2x Spravato® 28 mg nasal spray)
    56mg esketamine (2x Spravato® 28 mg nasal spray)
  • Drug: 0.9% saline solution nasal spray
    0.9% saline solution nasal spray
Study Arms  ICMJE
  • Experimental: first 56mg esketamine (2x Spravato® 28 mg nasal spray), then placebo
    Interventions:
    • Drug: 56mg esketamine (2x Spravato® 28 mg nasal spray)
    • Drug: 0.9% saline solution nasal spray
  • Experimental: first placebo (0.9% saline solution nasal spray), then ketamine
    Interventions:
    • Drug: 56mg esketamine (2x Spravato® 28 mg nasal spray)
    • Drug: 0.9% saline solution nasal spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2022)
33
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 22, 2024
Estimated Primary Completion Date April 22, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05320120
Other Study ID Numbers  ICMJE PSY-NIL-0011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rupert Lanzenberger, Medical University of Vienna
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rupert Lanzenberger
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP