Clinical TrialTreatment-Resistant Depression (TRD)KetamineKetamineKetamineCompleted

A Naturalistic Study of Ketamine for Treatment Resistant Mood Disorders

Open-label naturalistic study (n≈80) assessing repeated IV (0.5 mg/kg), intranasal, and oral (2.0–2.5 mg/kg) ketamine twice weekly for 4 weeks in patients with treatment-resistant mood disorders.

Target Enrollment
80 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

This prospective naturalistic study evaluates safety, tolerability, and effectiveness of repeated, individually tailored ketamine administered IV, intranasally and orally in inpatients with treatment‑resistant major depressive disorder and bipolar depression.

Dosing regimens include slow IV infusions (0.5 mg/kg over 40 minutes) and twice-weekly intranasal and oral administrations (oral 2.0–2.5 mg/kg), delivered over a 4‑week period; outcomes include clinical response, safety and tolerability measures.

Study Protocol

Preparation

sessions

Dosing

8 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine (IV, nasal, oral)

experimental

Open-label, individually tailored repeated ketamine dosing delivered IV, intranasal and oral across a 4-week twice-weekly schedule.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice weekly• 8 doses total

    Slow IV infusion 0.5 mg/kg over 40 minutes, twice weekly for 4 weeks.

  • Ketamine
    via Other• twice weekly• 8 doses total

    Intranasal ketamine spray, twice weekly for 4 weeks (dose not specified).

  • Ketamine2 - 2.5 mg/kg
    via Oral• twice weekly• 8 doses total

    Oral solution 2.0–2.5 mg/kg, twice weekly for 4 weeks.

Participants

Ages
18 – 90
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Major depressive disorder (MDD) or bipolar disorder (BD) diagnosis as provided by DSM-5 criteria
  • 2. TRD defined as the patient does not reach remission within the 8 week trial of an antidepressant or combination at a therapeutic dose of at least two trials of first-line evidence-based treatments and/or electroconvulsive therapy (ECT)

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Pregnancy and lactation
  • 2. Hypersensitivity to ketamine
  • 3. Uncontrolled hypertension
  • 4. Other uncontrolled somatic diseases that may impact safety per investigators judgement

Study Details

Locations

Department of Psychiatry, Medical University of Gdańsk — Gdansk, Poland

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