Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

A Multimodal Neuroimaging Study of Brain Activation Patterns Under Ketamine

Randomised, crossover neuroimaging study (n=10) comparing IV S-ketamine 0.25 mg/kg versus saline placebo in adults 20–60 to investigate glutamatergic mechanisms relevant to MDD.

Target Enrollment
10 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

This study used a multimodal imaging approach (ASL, task and resting fMRI, MRS, PET) to investigate region-specific effects of NMDA receptor antagonism with S-ketamine on glutamatergic neurotransmission and brain function relevant to major depressive disorder.

Healthy volunteers and depressed patients underwent two single IV infusion sessions (S-ketamine 0.25 mg/kg and saline placebo) in a randomised crossover design with acute and short-term neuroimaging and clinical assessments to link neural changes to emotional state and potential antidepressant mechanisms.

Outcomes included imaging measures of perfusion, connectivity, neurometabolism and receptor density alongside clinical scales to elucidate pharmacological effects of ketamine on glutamatergic systems.

Study Protocol

Preparation

sessions

Dosing

2 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

IV infusion of S-ketamine 0.25 mg/kg over 40 min (crossover).

Interventions

  • Ketamine0.25 mg/kg
    via IV• single dose• 1 doses total

    S-ketamine intravenous infusion over 40 minutes.

Placebo

inactive

IV saline infusion over 40 min (crossover).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Normal saline intravenous infusion over 40 minutes.

Participants

Ages
20 – 60
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • treatment resistant depressive episode
  • no restrictions regarding antidepressant medication

Exclusion Criteria

  • 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

Study Details

Locations

Switzerland

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