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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: 16 Dec 2024

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At a glance

  • Drugs Ketamine (Primary) ; Antidepressants
  • Indications Depression
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Ketabon
  • Most Recent Events

    • 11 Dec 2024 According to a HMNC Brain Health media release, the company has collaborated in a consortium of respected universities and institutions to win a 4.5m euros grant from the Austrian Research Promotion Agency (FFG). The consortium, which includes the Austrian Institute of Technology and the Danube Private University and others, will receive the funding over three years. This grant will be used for getting new analyses form this trial.
    • 18 Sep 2024 According to Ketabon Media Release, Combined Results from KET01-02 and KET01-03 Trials will be presented as posters at the 37th European College of Neuropsychopharmacology (ECNP) Congress 2024, taking place on September 21-24, 2024 in Milan.
    • 21 May 2024 According to Ketabon GmbH media release, the Company will present poster presentations at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting taking place on May 28-31, 2024 at Miami Beach.

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