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Updated: Jun 25, 2026

Robotically Delivered fMRI-Guided Personalized Transcranial Magnetic Stimulation Therapy for Treatment-Resistant Depression
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Oral Prolonged-Release Ketamine for Treatment-Resistant Depression: Two Randomized Clinical Trials.

Martin Walter1, Christine Zu Eulenburg2,3, Ani Damyanova2

  • 1Department of Psychiatry and Psychotherapy, University Hospital Jena, Jena, Germany.

JAMA Network Open
|June 24, 2026
PubMed
Summary
This summary is machine-generated.

A novel oral ketamine formulation, KET01, showed rapid antidepressant effects with minimal dissociation and cardiovascular side effects in clinical trials. Further development for at-home use is supported by its promising tolerability profile.

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Published on: January 7, 2019

Area of Science:

  • Pharmacology
  • Psychiatry
  • Clinical Trials

Background:

  • Ketamine offers rapid antidepressant effects but is limited by dissociative and cardiovascular adverse events.
  • Novel formulations aim to improve ketamine's therapeutic index for depression treatment.

Purpose of the Study:

  • To assess the antidepressant efficacy and tolerability of KET01, an oral, prolonged-release racemic ketamine tablet.
  • To compare KET01's safety and efficacy against intranasal esketamine and placebo.

Main Methods:

  • Two randomized clinical trials (RCTs): KET01-03 (Phase 1, healthy volunteers, KET01 vs. intranasal esketamine) and KET01-02 (Phase 2, treatment-resistant depression, KET01 vs. placebo).
  • Primary endpoints included dissociation (Clinician-Administered Dissociative States Scale) and depression scores (Montgomery-Åsberg Depression Rating Scale).

Main Results:

  • KET01 did not induce significant dissociation compared to intranasal esketamine.
  • No significant cardiovascular changes were observed with KET01, unlike intranasal esketamine.
  • KET01-02 did not meet its primary efficacy endpoint at 3 weeks, but showed early antidepressant effects at 4 and 7 hours, and sustained effects at 7 days.

Conclusions:

  • Oral KET01 demonstrates a favorable tolerability profile with minimal dissociation and cardiovascular effects.
  • The study supports further development of KET01 for at-home treatment of depression.
  • Early and sustained antidepressant effects warrant further investigation into KET01's therapeutic potential.