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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

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Ketamine Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Brain Activation Patterns Under Emotional and Neurochemic Stimulation With Ketamine: A Multimodal Neuroimaging Study
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine
i.v. infusion of 0.25 mg/kg S-ketamine over 40 min
Drug: Ketamine
i.v. infusion of 0.25 mg/kg S-ketamine over 40 min

Placebo Comparator: Placebo
i.v. infusion of NaCl over 40 min
Drug: Placebo
i.v. infusion of NaCl over 40 min




Primary Outcome Measures :
  1. Change in functional reactivity to emotional stimuli [ Time Frame: Change from baseline to 24h-post infusion ]
    fMRI BOLD

  2. Change in glutamate concentrations in prefrontal cortex [ Time Frame: Change from baseline to 24h-post infusion ]
    1H-MRS

  3. Change in resting-state functional connectivity [ Time Frame: Change from baseline to 24h-post infusion ]
    rsfMRI



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Milan Scheidegger, Principal Investigator, Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier: NCT03609190    
Other Study ID Numbers: E-31/2008
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action