Oral Prolonged-Release Ketamine for Treatment-Resistant Depression: Two Randomized Clinical Trials - Takeaways - MDSpire

Oral Prolonged-Release Ketamine for Treatment-Resistant Depression: Two Randomized Clinical Trials

  • By

  • Martin Walter

  • Christine zu Eulenburg

  • Ani Damyanova

  • Karin Schmid

  • Isabel Schwienbacher

  • Evangelos Papanastasiou

  • Katarina Maiboe

  • Lars Arvastson

  • Caren Strote

  • Daniel Gehrlach

  • Hans Eriksson

  • June 24, 2026

  • 0 min

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  • 1

    Ketamine has gained attention as a rapid-acting treatment for treatment-resistant depression (TRD) over the past two decades.

  • 2

    KET01 is a prolonged-release oral formulation of racemic ketamine designed to minimize dissociative effects and improve tolerability.

  • 3

    Two randomized clinical trials evaluated KET01's safety, tolerability, and antidepressant efficacy compared to intranasal esketamine and placebo.

  • 4

    The phase 1 trial compared a single dose of KET01 to intranasal esketamine in healthy males, focusing on dissociative symptoms.

  • 5

    The phase 2 trial involved adult outpatients with TRD, assessing the change in depression severity using the MADRS scale.

Original Source(s)

Oral Prolonged-Release Ketamine for Treatment-Resistant Depression: Two Randomized Clinical Trials

  • by Martin Walter, Christine zu Eulenburg, Ani Damyanova, Karin Schmid, Isabel Schwienbacher, Evangelos Papanastasiou, Katarina Maiboe, Lars Arvastson, Caren Strote, Daniel Gehrlach, Hans Eriksson

  • June 24, 2026

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