Clinical TrialMajor Depressive Disorder (MDD)KetamineUnknown status

An EEG Study of Intravenous Ketamine for Major Depression Disorder

This open-label trial (n=35) will assess the electroencephalographic (EEG) responses before, during, and after four weekly low-dose (60 mg) intravenous ketamine infusions in patients with major depressive disorder (MDD).

Target Enrollment
35 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

Open-label, single-arm study enrolling 35 adults with MDD to receive four 50–60 minute IV infusions of 60 mg ketamine on days 0, 7, 14 and 21; EEG recorded before, during and after infusions with a follow-up visit at 4 weeks post-treatment.

Objective is to characterise changes in EEG measures associated with ketamine treatment and to monitor safety and tolerability; clinical symptom measures (e.g., MADRS) and adverse events will be collected.

Study Protocol

Preparation

sessions

Dosing

4 sessions
60 min each

Integration

sessions

Therapeutic Protocol

other

Study Arms & Interventions

Ketamine

experimental

Open-label single-arm: four weekly IV ketamine infusions (60 mg) with EEG recording.

Interventions

  • Ketamine60 mg
    via IV• weekly• 4 doses total

    50–60 minute infusion per session; four infusions on days 0,7,14,21.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Individuals between 18 and 70 years of age, inclusive
  • 2. Adult patients with a documented primary Axis I clinical diagnosis meeting criteria from the DSM-V for a major depressive disorder
  • 3. Score of <15 on the DES
  • 4. Moderate to severe symptoms objectively documented using MADRS total score of ≥ 20
  • 5. Ability to maintain scheduled appointments for screenings, 4 treatment visits and follow-up EEG visit.
  • 6. History of major depressive disorder.
  • 7. Females of child-bearing potential who are sexually active must agree to use two forms of contraception. A pregnancy test will be performed before the first treatment.
  • 8. Must have stable residence address, internet and mobile phone.
  • 9. Must speak fluent English.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Known allergy to ketamine or any other drug used in the study.
  • 2. Use of ketamine in a therapeutic model within the preceding 12 months of the study.
  • 3. Current or any history of schizoaffective disorder(s).
  • 4. Score of ≥ 15 on DES
  • 5. History of illicit active substance abuse or dependence including ketamine as determined on by the SCID-5-CT and/or drug urine screening during study visits.
  • 6. Pregnancy, breastfeeding or desire to become pregnant during the course of the study.
  • 7. Serious, unstable illnesses including, but not limited to; hepatic, gastro-intestinal, respiratory, cardiovascular (including ischemic heart disease and coronary heart disease). History of ischemic stroke, atrial fibrillation, severe endocrinological, neurological, immunological or hematological disease.
  • 8. Any history of cerebral vascular events including stroke, bleeding into the brain and subdural hematomas.
  • 9. Any implantable metallic device(s) or implant(s) above the level of shoulders.
  • 10. Any non-removable metallic piercings.
  • 11. Patients with cochlear implants and non-removable hearing aids.
  • 12. Current use of: Dilantin, Depakote, Phenobarbital, Gabapentin, Pregabalin and Benzodiazepines. Certain candidates with long use of Benzodiazepines may qualify at PI's discretion.
  • 13. Severe labile hypertension.
  • 14. Significant uncontrolled hypertension (i.e., SBP > 150 mmHG, DBP > 100 mmHG)
  • 15. Uncontrolled diabetes mellitus.
  • 16. Patients on renal dialysis.
  • 17. Inability to achieve consistent IV access.

Study Details

  • Status
    Unknown status
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment35 participants
  • Timeline
    Start: 2023-01-01
    End: 2024-02-29
  • Compound
    Ketamine
  • Topic
    Major Depressive Disorder (MDD)

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