Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboKetaminePlaceboCompleted

Intra-nasal vs. Intra-venous Ketamine Administration

Randomised, parallel, Phase IV study (n=45) comparing intranasal ketamine (50 mg split into 5 doses) versus IV ketamine (0.2 mg/kg) for Major Depressive Disorder.

Target Enrollment
45 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomised, quadruple-blind, parallel-group trial compares intranasal ketamine (50 mg, delivered as five alternating-nostril doses) with IV ketamine (0.2 mg/kg IV push) in patients with Major Depressive Disorder and MADRS >20.

Patients failing to achieve response in the parallel phase may be offered an additional course of up to four 0.5 mg/kg ketamine infusions given twice weekly over two weeks (40-minute infusions). Primary outcome assessments include MADRS change; safety and tolerability monitored.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Active IV

active comparator

IV ketamine plus intranasal placebo (parallel design).

Interventions

  • Ketamine0.2 mg/kg
    via IV• single dose

    IV push 0.2 mg/kg; non-responders may be offered up to 4 additional 0.5 mg/kg infusions over 40 minutes.

  • Placebo50 mg
    via Other• single dose

    Intranasal saline placebo 50 mg delivered as 5 doses alternating nostrils.

Active IN

active comparator

Intranasal ketamine plus IV placebo (parallel design).

Interventions

  • Ketamine50 mg
    via Other• single dose

    Intranasal 50 mg delivered as 5 doses alternating nostrils; non-responders may be offered up to 4 additional 0.5 mg/kg IV infusions over 40 minutes.

  • Placebo0.2 mg/kg
    via IV• single dose

    IV saline placebo 0.2 mg/kg (IV push).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Age 18-65
  • 2. Diagnosis of MDD (Major Depressive Disorder), made or affirmed by a senior psychiatrist in Shalvata
  • 3. MADRS score > 20
  • 4. Treated with conventional anti-depressant, administered within a formal psychiatric clinic or by a certified psychiatrist.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Active or past psychotic disorder, including a history of psychotic affective state
  • 2. Mental Retardation or Autistic Spectrum Disorder
  • 3. Prominent personality disorder
  • 4. Cardiac or neurologic active medical condition, including past CVA/TIA or any other unstable medical condition
  • 5. Chronic nasal congestion
  • 6. Active or recent drug or alcohol abuse
  • 7. Substantial suicidality requiring admission who refuses admission and signs against-medical-advice release form and does not meet terms for involuntary admission.

Study Details

Locations

Shalvata MHC — Hod HaSharon, Israel

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