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A Multimodal Neuroimaging Study of Brain Activation Patterns Under Ketamine

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ClinicalTrials.gov Identifier: NCT03609190
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Milan Scheidegger, Psychiatric University Hospital, Zurich

Tracking Information
First Submitted Date  ICMJE July 13, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • Change in functional reactivity to emotional stimuli [ Time Frame: Change from baseline to 24h-post infusion ]
    fMRI BOLD
  • Change in glutamate concentrations in prefrontal cortex [ Time Frame: Change from baseline to 24h-post infusion ]
    1H-MRS
  • Change in resting-state functional connectivity [ Time Frame: Change from baseline to 24h-post infusion ]
    rsfMRI
Original Primary Outcome Measures  ICMJE Same as current
Change History
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 A Multimodal Neuroimaging Study of Brain Activation Patterns Under Ketamine
Official Title  ICMJE Brain Activation Patterns Under Emotional and Neurochemic Stimulation With Ketamine: A Multimodal Neuroimaging Study
Brief Summary

The aim of the project is to establish a multimodal imaging approach for the investigation of the neural mechanisms underlying neuroreceptor regulation, glutamatergic metabolism and brain function that are of particular relevance for major depressive disorder (MDD) and that can be translated into clinical applications.

There is growing evidence for imbalance with regard to glutamatergic neurotransmission in stress-related affective disorders. Further support for the hypothesis that dysfunctional glutamatergic signaling underlies major depressive disorder, and indeed that its reversal constitutes a potential efficacious mechanism of action, is provided by the evidence that pharmacological compounds active at the N-methyl-D-aspartate (NMDA) ionotropic glutamate receptor such as ketamine exert rapid antidepressant effects. As a tool compound ketamine enables the safe investigation of the brain region-specific effects of NMDA receptor antagonism in terms of glutamatergic neurotransmission, brain function and the association of these neural changes with emotional state, thereby allowing for increased understanding of the therapeutic mechanism of action.

The possibility to simultaneously study brain perfusion (arterial spin labeling), functional brain activity (fMRI) and connectivity (resting state fMRI), neurometabolism (proton magnetic resonance spectroscopy) and metabotropic glutamate receptor densities (positron emission tomography) will unravel their functional interplay in the mechanisms underlying the regulation of mood and cognition. Combining those imaging modalities with treatment interventions in healthy subjects and depressed patients, this project aims at providing insight into the neuropharmacological effects of ketamine and its antidepressant properties.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Ketamine
    i.v. infusion of 0.25 mg/kg S-ketamine over 40 min
  • Drug: Placebo
    i.v. infusion of NaCl over 40 min
Study Arms  ICMJE
  • Experimental: Ketamine
    i.v. infusion of 0.25 mg/kg S-ketamine over 40 min
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    i.v. infusion of NaCl over 40 min
    Intervention: Drug: Placebo
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2019)
10
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2018)
30
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • treatment resistant depressive episode
  • no restrictions regarding antidepressant medication

Exclusion Criteria:

  • lifetime antidepressant treatment with ketamine
  • lifetime recreational use of ketamine
  • cardiovascular diseases such as hypertonia, cardiac insufficiency or myocardial infarct in the past six months
  • insufficiently treated anemia
  • hyper- or hypothyroidism
  • lifetime increased intracranial pressure or glaucoma
  • chronic physical diseases
  • hepatorenal dysfunction
  • any relevant psychiatric or neurological comorbidity, in particular dementia, epileptic seizures (lifetime), schizophrenia (lifetime), psychosis (lifetime), or post-traumatic stress disorder (current).
  • acute suicidality
  • substance abuse disorders
  • recent heart or head surgery
  • metallic body implants
  • agoraphobia
  • pregnancy
  • left handedness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03609190
Other Study ID Numbers  ICMJE E-31/2008
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
Plan to Share IPD: No
Responsible Party Milan Scheidegger, Psychiatric University Hospital, Zurich
Study Sponsor  ICMJE Psychiatric University Hospital, Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Psychiatric University Hospital, Zurich
Verification Date March 2019

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