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A multicentre, double-blind, randomised, placebo-controlled phase II trial with a 3 week treatment period to assess the efficacy, safety and tolerability of add-on treatment with Ketamine hydrochloride prolonged release tablets (KET01, 120 mg or 240 mg once daily) in outpatients with treatment resistant depression

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Trial Profile

A multicentre, double-blind, randomised, placebo-controlled phase II trial with a 3 week treatment period to assess the efficacy, safety and tolerability of add-on treatment with Ketamine hydrochloride prolonged release tablets (KET01, 120 mg or 240 mg once daily) in outpatients with treatment resistant depression

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Jul 2026

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At a glance

  • Drugs Ketamine (Primary) ; Antidepressants
  • Indications Treatment-resistant depressive disorder
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Ketabon

Most Recent Events

  • 07 Jul 2026 According to HMNC Brain Health Media Release, data from the trial were presented in JAMA Network.
  • 07 Jul 2026 Results presented in the HMNC Brain Health Media Release
  • 15 Oct 2025 According to a Ketabon GmbH media release, new data from a post hoc analysis of this trial at the European College of Neuropsychopharmacology (ECNP) 38th Annual Congress in Amsterdam.

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