Clinical TrialMajor Depressive Disorder (MDD)KetamineWithdrawn

Repeated Neurocognitive Measurements in Depressed Patients 2025

Single-group interventional study (n=20) conducting repeated neurocognitive and neurobiological measurements in unipolar depressed patients, with a ketamine substudy using a single 0.5 mg/kg IV infusion.

Target Enrollment
20 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

This project longitudinally tracks candidate neurobiological targets for depression and relates fluctuations in those targets to real-world functioning in people with unipolar depression.

In a nested ketamine subsample, participants receive a single open-label racemic ketamine infusion (0.5 mg/kg over 40 minutes) to assess acute modulation of those targets and associated cognitive and functional changes.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Intravenous Ketamine

experimental

Open-label ketamine infusion (single group).

Interventions

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

    Racemic ketamine 0.5 mg/kg infused over 40 minutes (Ketalar).

Participants

Ages
18 – 60
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • All participants will:
  • 1. be between the ages of 18 and 60 years,
  • 2. score ≥ 14 on the Hamilton Depression Rating Scale (Ham-D)
  • 3. possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document

Exclusion Criteria

  • Exclusion Criteria:
  • All participants:
  • 1. Presence of lifetime bipolar, psychotic, or autism spectrum disorder; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);
  • 2. Failure to meet standard MRI inclusion criteria: pacemakers, neural pacemakers, cochlear implants, metal braces, or other non-MRI-compatible metal objects in their body. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results.
  • 3. Acute suicidality or other psychiatric crises requiring treatment escalation. CSSRS used for screening and rescue/removal: subjects with CSSRS items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded and referred for emergency care.
  • 4. Changes made to treatment regimen within 4 weeks of baseline assessment.
  • 5. Reading level <6th grade by self-report.
  • 6. Patients who have received ECT in the past 2 months prior to Screening.
  • Ketamine phase subsample additional exclusion criteria:
  • 1. Patients currently taking any psychotropic medication.
  • 2. Lifetime recreational ketamine or PCP use.
  • 3. Current pregnancy or breastfeeding.
  • 4. Not a reasonable medical candidate for ketamine infusion (serious/unstable medical illnesses including respiratory [obstructive sleep apnea], or history of difficulty with airway management during previous anesthetics; cardiovascular [including ischemic heart disease and uncontrolled hypertension]; neurologic [including history of severe head injury]).
  • 5. Clinically significant abnormal laboratory parameters (including urine toxicology), physical exam, or ECG.
  • 6. Uncontrolled or poorly controlled hypertension.
  • 7. History of one or more seizures without a clear and resolved etiology.
  • 8. Starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.
  • 9. Past intolerance or hypersensitivity to ketamine.
  • 10. Patients taking medications with known activity at the NMDA or AMPA glutamate receptor (e.g., riluzole, amantadine, memantine, topiramate, dextromethorphan, D-cycloserine), or the mu-opioid receptor.
  • 11. Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.

Study Details

  • Status
    Withdrawn
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2024-05-01
    End: 2025-12-31
  • Compound
    Ketamine
  • Topic
    Major Depressive Disorder (MDD)

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