Actively Recruiting
A Clinical Trial of Add-on Oral Slow-release Ketamine Treatment in Major Depression
Led by Daniel Lindqvist · Updated on 2026-05-04
12
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
D
Daniel Lindqvist
Lead Sponsor
K
Ketabon
Collaborating Sponsor
AI-Summary
What this Trial Is About
* 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
Official Title
A Clinical Trial of Add-on Oral Slow-release Ketamine Treatment in Major Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written consent to participate in the trial
- Body mass index (BMI) between 18 and 35 kg/m2
- Primary diagnosis of Major Depressive Disorder (MDD) meeting DSM-5-TR criteria with specific episode types: single moderate, single severe without psychotic features, recurrent moderate, or recurrent severe without psychotic features
- Current depressive episode lasting no longer than 12 months before screening
- Montgomery-Åsberg Depression Rating Scale (MADRS) score of 22 or higher at screening
- Willingness to start a new conventional antidepressant treatment alongside ketamine tablets as prescribed
- Willingness to stop any current antidepressant treatment if deemed ineffective, including a 7-day medication-free washout before starting new treatment
- For females of childbearing potential: willingness to undergo pregnancy tests and use highly effective contraception from consent until 28 days after last study drug intake
- For male participants with partners of childbearing potential: willingness to use adequate contraception or practice sexual abstinence from consent until 28 days after last study drug intake
You will not qualify if you...
- Known allergy or intolerance to ketamine or any tablet ingredients
- Pregnancy, breastfeeding, or planned pregnancy
- High suicide risk as assessed by the study physician
- Certain psychiatric or neurological conditions including MDD with psychotic features, schizophrenia spectrum disorders, bipolar disorder, specific personality disorders, neurodevelopmental disorders, or autism spectrum disorder
- History of brain surgery, encephalitis, meningitis, degenerative CNS disorders, epilepsy (except uncomplicated childhood febrile seizures), significant head trauma in past 2 years, or cerebrovascular events
- Ongoing or unstable cardiac disease or significant abnormal ECG findings
- Untreated or uncontrolled high blood pressure
- Liver impairment or cirrhosis indicated by certain abnormal lab tests
- Hepatitis B or C infection
- Kidney impairment or dialysis
- Diabetes with high HbA1c values
- Hyperthyroidism or unstable hypothyroidism
- Recent complicated cystitis within 5 years
- Other significant diseases or conditions that may increase risk or interfere with study
- Previous ketamine or esketamine use (except anesthesia)
- Use of prohibited medications or therapies
- History of moderate to severe alcohol or substance use disorder within 6 months
- Participation in other treatment studies
- Ongoing electroconvulsive therapy or repetitive transcranial magnetic stimulation
- Ongoing compulsory psychiatric care
- Any condition preventing trial completion or compliance
- Recent or planned psychotherapy within 6 weeks before or during the trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Adult Psychiatry
Lund, Skåne County, Sweden, 22240
Actively Recruiting
Research Team
M
Mirjam Wolfschlag, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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