Actively Recruiting
A Pilot Phase II Trial of Add-on Oral Slow-Release Ketamine Tablets During Antidepressant Therapy Initiation in Major Depressive Disorder
Led by Daniel Lindqvist · Updated on 2026-05-04
12
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
D
Daniel Lindqvist
Lead Sponsor
K
Ketabon
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding ketamine tablets to standard antidepressant therapy can reduce depressive symptoms in adults with Major Depressive Disorder (MDD). This pilot Phase II trial focuses on whether ketamine, given alongside a new antidepressant, decreases depression symptoms measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) after one week of treatment. The study includes adults aged 18 to 75 years with moderate to severe single or recurrent MDD episodes. Participants will receive four doses of Ketamine Hydrochloride Prolonged-Release Tablets (240 mg) over eight days at the clinic while starting a new standard antidepressant chosen by their physician. The ketamine treatment ends after one week, but the antidepressant therapy continues. This trial includes only one treatment group with all enrolled patients receiving ketamine alongside antidepressants. During the study, participants complete various questionnaires and rating scales at screening, treatment, and follow-up visits. Blood samples are collected at five visits to monitor side effects and explore biomarkers. Follow-up continues for three weeks after ketamine treatment ends, with assessments of depression severity, anxiety, suicide risk, physical activity, sleep patterns, and inflammatory biomarkers. The total participation lasts about four weeks.
CONDITIONS
Brief 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...
- Provided written consent to participate
- Body mass index between 18 and 35 kg/m2
- Primary diagnosis of Major Depressive Disorder meeting DSM-5-TR criteria, with specified moderate or severe episode types
- Current depressive episode duration no longer than 12 months prior to screening
- Montgomery-Åsberg Depression Rating Scale score of at least 22 at screening
- Willing to start a new standard antidepressant treatment alongside ketamine tablets
- Willing to stop any ongoing antidepressant treatment if deemed ineffective, with at least 7 days washout before starting new treatment
- For females of childbearing potential: willing to undergo pregnancy tests and use highly effective contraception until 28 days after last drug intake
- For males with partners of childbearing potential: willing to use barrier contraception or abstain from sex until 28 days after last drug intake
You will not qualify if you...
- Known allergy or intolerance to ketamine or its ingredients
- Pregnancy, breastfeeding, or planning pregnancy
- High suicide risk as assessed by the study physician
- Certain psychiatric or neurological conditions including psychotic features, bipolar disorder, schizophrenia spectrum, or specific personality disorders
- History of brain surgery, CNS disorders, epilepsy (except simple childhood febrile seizures), or significant head trauma in past 2 years
- History of stroke or cerebrovascular events
- Ongoing or unstable heart disease or abnormal ECG that risks safety
- Untreated or uncontrolled high blood pressure
- Significant liver dysfunction or hepatitis B or C
- Kidney impairment or dialysis
- Diabetes with high HbA1c at screening
- Uncontrolled thyroid disorders
- Recent complicated cystitis or recurrent infections
- Other serious diseases or conditions risking safety or study conduct
- Previous use of ketamine or esketamine except anesthesia
- Use of prohibited medications or therapies
- History of moderate to severe substance use disorder within 6 months
- Participation in other treatment studies
- Current electroconvulsive therapy or repetitive transcranial magnetic stimulation
- Ongoing compulsory psychiatric care
- Recent or planned psychotherapy within 6 weeks
- Any reason judged by the investigator that prevents safe participation or trial completion
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week (8 days)
Participants receive oral slow-release ketamine tablets as an add-on to antidepressant therapy for major depressive disorder.
Visits on day 1, 3, 5, and 8
Duration - 3 weeks (up to day 29)
Participants are monitored after treatment to assess changes in depression symptoms, anxiety, sleep, physical activity, inflammatory biomarkers, and personal experience with treatment effects.
Visits on day 15 and day 29
Trial Site Locations
Total: 1 location
1
Adult Psychiatry
Lund, Skåne County, Sweden, 22240
Actively Recruiting
Research Team
M
Mirjam Wolfschlag, PhD
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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