Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboRecruiting

The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects

Phase I, randomised, placebo-controlled crossover study (n=60; 25 MDD patients, 35 healthy controls) assessing IV subanaesthetic ketamine (0.5 mg/kg) vs saline during MRI to investigate effects on aesthetic processing and role in antidepressant/anhedonia mechanisms.

Target Enrollment
60 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

This single-centre, randomised crossover study will assess 25 patients with major depressive disorder and 35 healthy controls twice with MRI — once after IV ketamine (subanaesthetic dose) and once after saline placebo — to evaluate changes in aesthetic perception and reward processing.

Imaging includes structural, resting-state and task-based fMRI (aesthetic processing, reward, sexual arousal). Clinical scales for depression, anhedonia and aesthetic processing will be collected; eligibility is assessed at screening and a follow-up visit completes participation.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Ketamine vs Placebo

experimental

Single-centre, randomised, placebo-controlled crossover comparing IV subanaesthetic ketamine to saline during MRI sessions.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Planned dose 0.5 mg/kg; pilot may use 0.25 mg/kg.

  • Placebo
    via IV• single dose• 1 doses total

    0.9% NaCl saline placebo.

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • General health based on medical history and physical examination
  • Psychiatric health based on structured clinical interview for DSM-5 (SCID) for healthy controls
  • Major depressive episode (first or recurrent) based on structured clinical interview for DSM-5 and ICD-10 for patients
  • Age 18 to 55 years
  • Right-handedness (due to potential lateralization effects of lefthanded subjects)
  • Willingness and competence to sign the informed consent form

Exclusion Criteria

  • Exclusion Criteria:
  • Current or history of neurological disease
  • Current medical illness requiring treatment
  • Psychiatric diagnosis for healthy individuals
  • Psychiatric comorbidity with the exception of anxiety disorders for depressed individuals
  • Pregnancy or current breastfeeding
  • Current or former substance abuse
  • Previous ketamine use in lifetime
  • 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

Study Details

Locations

Medical University of Vienna — Vienna, Austria

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