Researchers Announce Positive Results from Phase 2 At-Home Ketamine Trial

The Phase 2 KET01-02 Ketabon trial focused on KET101 as an oral adjunctive at-home treatment for patients with treatment-resistant depression (TRD) showed significant improvements in depression severity, according to new study results.

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TRD is a progressive condition that effects nearly 100 million individuals in the United States with very minimal treatment options.

The trial involved 122 outpatients with TRD who were currently experiencing depressive episodes and did not show improvements with 2 standard antidepressants. The dosing options were 120 mg/day KET01, 240 mg/day KET01, or a placebo once daily with their standard antidepressant for 3 weeks. The main goals of the trial were to test the efficacy and safety of KET01.

According to the study, the participants that received the 240mg/day dose showed improvements in depressive severity by day 4 of the dose compared to the placebo. The study authors note that the patients were checked after 4 weeks and saw continued improvement. The placebo group also reported improvement over time and reached a statistical significance at the end of the 3-week trial.

“We are highly encouraged by the top-line results of KET01-02, which have the potential to transform the treatment landscape for patients continuing to suffer from TRD,” said HMNC Brain Health's Chief Medical Officer, Hans Eriksson, MD, PhD. “Notably, these results were not associated with a signal of dissociative symptoms, as measured by the Clinician-Administered Dissociative States Scale—or CADSS—suggesting that the oral prolonged-release administration has the potential to be a robust antidepressant that offers better tolerability than other forms of ketamine-based treatments.”

The study authors noted that other ketamine-based treatments could increase heart rate and blood pressure, but KET01 has not shown those effects.

“KET01 offers rapid improvement of depressive symptoms while the occurrence of dissociative events interestingly seems to be lower than in currently used ketamine-based treatments. This could lead to wider and more convenient, private at-home use,” said Martin Walter, MD, FECSM, Chair and Head of the Department of Psychiatry and Psychotherapy at University Jena, and international coordinating investigator of the study.

The findings suggest that KET01 could successfully treat TRD while limiting adverse effects, potentially adding a treatment option for the condition.

Reference:

Ketabon GmbH Reports Top-Line Results from Phase 2 Trial of Take-at-Home, Oral Ketamine Option for Treatment-Resistant Depression. Ketabon Health. News release. August 14, 2023. Accessed August 23, 2023.