Clinical TrialParallelKetamineKetaminePlaceboCompleted

KET01 Oral Prolonged-Release Ketamine for TRD: 3-Arm RCT (Colla 2024, 3 Swiss Hospitals)

Three-arm double-blind RCT at three Swiss psychiatric hospitals (J Psychiatr Res 2024; Colla M, Offenhammer B, Scheerer H, Kronenberg G; PMID 38522166; April 2019 – December 2021, with COVID-19 recruitment hiatus). Study code: KET01. Registered on Swiss National Clinical Trials Portal (SNCTP); registration number not recoverable from methods. Participants: adults 18–70, ICD-10 major depressive episode, MADRS ≥19, failed ≥2 adequate antidepressant trials, BMI 18–30; exclusions: psychosis/dementia, active suicidality, substance dependence, serious medical comorbidity. 1:1:1 block randomisation (block size 6, stratified by age/sex/weight) to: placebo vs KET01 160 mg/day (80 mg BID) vs KET01 240 mg/day (120 mg BID) for 14 days. Ongoing antidepressants maintained without washout. Target: n=33/arm (n=99 total); recruitment curtailed before target. Primary outcome: MADRS change baseline to day 15; MADRS also assessed days 1, 2, 4, 7, 11. CT.gov: 0 hits.

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

Study Protocol

Preparation

sessions

Dosing

14 sessions

Integration

sessions

Study Arms & Interventions

KET01 160mg

experimental

Oral prolonged-release ketamine (KET01) 160 mg/day, administered as 80 mg twice daily (between 8-9 a.m. and 5-6 p.m.) for 14 days as add-on therapy.

Interventions

  • Ketamine160 mg
    via Oral• twice daily• 14 doses total

    Prolonged-release formulation (KET01); administered as 80 mg twice a day.

KET01 240mg

experimental

Oral prolonged-release ketamine (KET01) 240 mg/day, administered as 120 mg twice daily for 14 days as add-on therapy.

Interventions

  • Ketamine240 mg
    via Oral• twice daily• 14 doses total

    Prolonged-release formulation (KET01); administered as 120 mg twice a day.

Placebo

placebo

Placebo administered for 14 days as add-on therapy.

Interventions

  • Placebo
    via oral• null

    Double-blind placebo control.

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment99 participants
  • Timeline
    Start: 2019-04-01
    End: 2021-12-01
  • Compounds
    KetamineKetaminePlacebo

Related Publications

PaywallindividualPrimary

Oral prolonged-release ketamine in treatment-resistant depression - A double-blind randomized placebo-controlled multicentre trial of KET01, a novel ketamine formulation - Clinical and safety results

This double-blind, randomised study (n=27) assessed the antidepressant effects of a novel oral prolonged-release formulation of racemic ketamine (KET01) in TRD patients as add-on therapy. Patients received either 160 mg/day or 240 mg/day KET01 or placebo for 14 days, with the primary endpoint being the change in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline to day 15. Results suggest a positive trend towards antidepressant efficacy with 240 mg/day KET01.

Published
Journal
Journal of Psychiatric Research
Authors
Colla, M., Offenhammer, B., Scheerer, H., Kronenberg, G., Vetter, S., Mutschler, J., Mikoteit, T., Bankwitz, A., Adank, A., Schaekel, L., Eicher, C., Brühl, A. B., Seifritz, E.

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