Clinical TrialMajor Depressive Disorder (MDD)EsketamineRecruiting

Study of the Neural Circuits Underlying the Negative Emotional Bias of Depressive Disorders and Their Response to Ketamine (EMOKET)

Open-label interventional parallel study (n=96) comparing depressed patients treated with esketamine (Spravato) with healthy volunteers using fMRI emotional tasks, behavioural measures and biological profiling.

Target Enrollment
96 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

This non-randomised parallel study will compare depressed patients receiving esketamine with healthy controls using fMRI emotional tasks and pupillometry to investigate neural circuits underlying negative emotional bias.

Assessments include tasks using validated image banks, behavioural measures of emotional valence, anatomical and functional MRI (~90 min), and biological investigations of immuno-inflammatory profiles and mRNA editing; clinical response measured by MADRS at 4 weeks with early change after dosing evaluated as a predictor.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Patients (esketamine)

experimental

Depressed patients receiving esketamine (Spravato) with neuroimaging, behavioural tasks and biological investigations.

Interventions

  • Esketamine
    via Other• per clinical decision

    Esketamine (Spravato) administered as decided by treating psychiatrist; local clinical dosing protocol.

  • Compound
    via Other• single session

    fMRI with emotional task and pupillometry (~90 min; task ~20 min).

  • Compound
    via Other• single session

    Behavioral task with emotional facial expressions (≈10 min).

  • Compound
    via Other• single session

    Biological investigation: immuno-inflammatory profiling and analysis of 8 mRNA editing variants.

Healthy controls

inactive

Healthy volunteers undergoing the same imaging, behavioural and biological assessments (no esketamine).

Interventions

  • Compound
    via Other• single session

    fMRI with emotional task and pupillometry (~90 min).

  • Compound
    via Other• single session

    Behavioral task with emotional facial expressions (≈10 min).

  • Compound
    via Other• single session

    Biological investigation: immuno-inflammatory profiling and mRNA editing analysis.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Patient inclusion criteria:
  • Age over 18
  • Patient hospitalised or consulting at GHU Paris Psychiatrie et Neurosciences
  • Major depressive episode (unipolar or bipolar) diagnosed according to DSM-5
  • MADRS score > 20
  • A course of esketamine has been decided by the treating psychiatrist
  • Written informed consent
  • Patient covered by a social security plan
  • Inclusion criteria for control subjects:
  • Over 18 years old
  • No depressive disorder assessed by MADRS < 8

Exclusion Criteria

  • Exclusion Criteria:
  • Patient non-inclusion criteria:
  • Psychiatric comorbidities: schizophrenia or schizoaffective disorder; history of recreational ketamine use
  • Protected adults or persons under legal protection
  • Contraindications to MRI, including refusal to be informed of clinically significant MRI findings
  • Pregnant or breastfeeding women
  • Usual contraindications to esketamine:
  • * Neurological comorbidity: epilepsy, neurodegenerative disease, recent cerebrovascular event (<3 months)
  • * Cardiological comorbidity: vascular aneurysm, ischemic heart disease with recent acute elements or stent within 12 months, uncontrolled hypertension, heart failure, rhythm or conduction disorders on ECG
  • * History of cirrhosis or elevated liver enzymes (ALAT, ASAT) or bilirubin >2× normal
  • * Severe chronic respiratory insufficiency
  • Exclusion criteria for control subjects:
  • MADRS >= 8
  • Contraindications to MRI, including refusal to be informed of clinically significant MRI findings

Study Details

Locations

- Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences — Paris, Paris, France

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