RecruitingPhase 2NCT07396272

A Clinical Trial of Add-on Oral Slow-release Ketamine Treatment in Major Depression

A Pilot, Open-label Phase II Trial of Adjunctive Treatment With Ketamine Hydrochloride Prolonged-Release Tablets (KET01) During the Initiation of Antidepressant Therapy in Major Depressive Disorder

Sponsor

Daniel Lindqvist

Enrollment

12 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)

Summary

* The goal of this clinical trial is to explore if the treatment with ketamine tablets in addition to standard antidepressant therapy can reduce depressive symptoms in adults with Major Depressive Disorder. The main question it aims to answer is: Does adjunctive ketamine therapy reduce depressive symptoms after one week of treatment compared to baseline, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)? * Participants will start ketamine treatment together with a new standard antidepressant. During the treatment week, patients will receive four doses of Ketamine Hydrochloride Prolonged-Release Tablets (240 mg) at the clinic. They will fill in different questionnaires and rating scales during screening, treatment and follow-up, and will leave blood samples at five of the visits to monitor side effects and identify possible biomarkers. After a week, the ketamine treatment is finished while the standard antidepressant therapy continues. The participation in this trial is completed after three aditional weeks of follow-up.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a slow-release oral form of ketamine as an add-on treatment for adults with moderate-to-severe major depression that has not fully responded to standard antidepressants. Ketamine has shown promise in treating depression quickly, and this study tests whether a convenient oral version taken at home can help. **You may be eligible if...** - You are 18 or older with a BMI between 18 and 35 - You have a primary diagnosis of moderate or severe major depressive disorder (MDD) based on DSM-5 criteria - You have been on an adequate dose of an antidepressant for at least 6 weeks without full relief - You are able to give written informed consent **You may NOT be eligible if...** - You have a history of psychosis, bipolar disorder, or schizophrenia - You have a current or recent substance use disorder - You are pregnant, breastfeeding, or planning to become pregnant - You have uncontrolled serious medical conditions (heart, liver, kidney) - You are at active risk of suicide requiring immediate intervention Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTreatment with Ketamine Hydrochloride Prolonged-Release Tablets

Only intervention of this pilot study, administered to all 12 patients enrolled. Treatment with Ketamine Hydrochloride Prolonged-Release Tablets (KET01, 240 mg) for one week (8 days) with four doses.