Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

Investigation of antidepressant efficacy of oral ketamine treatment

Double‑blind, randomised, parallel‑group Phase II trial (n=60) comparing oral ketamine versus oral midazolam in adults (18–64) with a major depressive episode to assess antidepressant efficacy.

Target Enrollment
60 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double‑blind, controlled Phase II study conducted in Austria assessing the antidepressant efficacy and tolerability of an oral ketamine formulation (Ketamin‑hameln) versus oral midazolam (Dormicum) in patients with a major depressive episode.

Primary outcome was change in MADRS measured before each treatment session, 24 hours after the first treatment session, and one and two weeks after the last treatment session; secondary assessments included CADSS for dissociative symptoms.

Sponsor: Medical University of Vienna; single‑site trial in Austria; IMPs were marketed formulations (Ketamin‑hameln and Dormicum) used orally per protocol details.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Oral ketamine

experimental

Oral ketamine (Ketamin‑hameln) solution for oral use; parallel-group active comparator design.

Interventions

  • Ketamine
    via Oral

    Ketamine hydrochloride oral formulation (Ketamin‑hameln); concentration reported 57.7 mg/ml; dose not specified in registry summary.

Midazolam (Dormicum)

active comparator

Active comparator arm receiving oral midazolam (Dormicum).

Interventions

  • Placebo
    via Oral

    Midazolam hydrochloride (Dormicum) oral solution, 1 mg/ml; used as active comparator (trade name Dormicum).

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Diagnosis of a major depressive episode in the scope of major depressive or bipolar disorder supported by SCID (DSM‑IV‑TR)
  • MADRS score ≥ 19
  • Willingness and competence to sign informed consent
  • Age 18–64 years
  • Stable psychopharmacological treatment for ≥10 days (except benzodiazepines)

Exclusion Criteria

  • Initiation of a new antidepressant or mood‑stabilising treatment within 4 weeks prior to inclusion
  • Prior use of ketamine
  • Pregnancy or breastfeeding
  • Unstable arterial hypertension >170/110 mmHg
  • Hepatic dysfunction
  • Hyperthyroidism
  • History of glaucoma
  • Neurodegenerative disorders
  • Any unstable medical illness
  • History of substance abuse within the past 12 months
  • History of psychosis
  • Failure to comply with the study protocol or investigators' instructions
  • Current treatment with clopidogrel, carbamazepine, valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine, phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial chemotherapeutics, azole antifungals, systemic glucocorticoids, ciclosporin, valeriana/garlic/grapefruit preparations, or St. John's wort

Study Details

Locations

Austria

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