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

NCT07396272 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-06-18

No results posted yet for this study

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.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

DRUG

Treatment 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.

Sponsors & Collaborators

  • Ketabon

    collaborator UNKNOWN

  • Lund University

    collaborator OTHER

  • Daniel Lindqvist

    lead OTHER

Principal Investigators

  • Daniel Lindqvist, PhD, MD · Region Skane

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-13
Primary Completion
2026-07-06
Completion
2026-10-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07396272 on ClinicalTrials.gov