Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboCompleted

Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality

Randomized, triple-blind, parallel trial (n=36) evaluating two IV infusions of ketamine (0.5 mg/kg each) versus placebo in patients with treatment-resistant MDD and suicidality.

Target Enrollment
36 participants
Study Type
Phase NA interventional
Design
Randomized, triple Blind

Detailed Description

This parallel-group, randomized, triple-blind trial assessed the onset, magnitude and duration of antidepressant effect of two IV ketamine infusions (0.5 mg/kg each) compared with placebo in patients with treatment-resistant major depressive disorder with suicidal risk.

Primary outcomes include antidepressant response timing and change in suicidal ideation; safety monitoring included adverse events and vital signs. Actual enrollment recorded as 36 at Assiut University, Egypt.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Two IV infusions of ketamine (0.5 mg/kg) in parallel-group active arm.

Interventions

  • Ketamine0.5 mg/kg
    via IV• two infusions• 2 doses total

    IV infusion, 0.5 mg/kg per infusion

Placebo

inactive

Placebo IV infusions in parallel-group comparator arm.

Interventions

  • Placebo
    via IV• two infusions• 2 doses total

    Placebo IV infusion

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Patients fulfilling diagnostic criteria of treatment-resistant MDD.
  • Presence of suicidal risk.
  • No comorbid medical or neurological conditions.
  • Age above 18 years old.
  • Both genders.
  • Informed written consent from the patient or legitimate representative.

Exclusion Criteria

  • Presence of perceptual disturbance.
  • History of sensitivity to ketamine.
  • Refusal to participate in the study.

Study Details

Locations

Assiut university — Asyut, Egypt

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