A study of ketamine hydrochloride as an additional treatment for patients starting standard antidepressants for major depression

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What is this study about?

This study focuses on individuals living with Major Depressive Disorder, a mental health condition that causes persistent feelings of sadness and a loss of interest in activities. The purpose of the study is to evaluate the early effectiveness of a new treatment used alongside standard antidepressant medications. The treatment being tested is a medication called KET01, which is a ketamine hydrochloride prolonged release tablet. This specific form of medicine is designed to release the drug into the body slowly over time through oral intake.

During the trial, participants will take the KET01 tablets in addition to their usual antidepressant therapy. The course of the study involves regular check-ins to monitor how the combination of medications affects mood and overall well-being over a period of several weeks.

1 baseline assessment

on day 1, initial measurements are taken to establish a starting point. this includes assessments using the montgomery-åsberg depression rating scale (madrs), which is a tool used to measure the severity of depression symptoms.

other evaluations are performed, such as the clinical global impression – severity (cgi-s) scale to rate symptom severity and the clinical global impression – efficacy index (cgi-e) to assess how well a treatment is working.

measurements regarding anxiety, suicidal thoughts, physical activity levels, and sleep patterns are recorded.

blood samples are collected to check for markers of inflammation, which are substances in the blood that indicate the body’s immune response.

dna methylation patterns, which are chemical changes that affect how genes work, are also assessed.

2 medication administration and monitoring

the treatment involves taking ketamine hydrochloride prolonged-release tablets. this is a slow-release version of the medication, meaning it is released into the body gradually over time.

the dose is 240 mg taken orally (by mouth).

this medication is used as an adjunctive treatment, which means it is taken alongside a standard antidepressant medication to complement its effects.

3 follow-up assessments

assessments using the madrs, cgi-s, and cgi-e scales are conducted on day 3 and day 5 to monitor changes in depression symptoms.

on day 8, a primary evaluation is performed using the madrs scale to measure the change in symptoms after one week of treatment. blood samples, dna methylation patterns, and assessments for suicidal thoughts are also completed on this day.

on day 15, follow-up evaluations are conducted for depression (phq-9), inflammation-related symptoms, anxiety (gad-7), physical activity, sleep patterns, and suicidal thoughts.

on day 29, final assessments are completed for depression, anxiety, physical activity, sleep, blood inflammation markers, dna methylation, and resilience.

at the final follow-up on day 29, a qualitative interview is conducted to discuss the personal experience regarding how the ketamine treatment has affected mood.

Who Can Join the Study?

The person must be between 18 and 75 years old.
The person must have a Body Mass Index (BMI), which is a measure of body fat based on height and weight, between 18 and 35 kg/m2.
The person must have a diagnosis of Major Depressive Disorder (MDD), which is a mental health condition characterized by persistent feelings of sadness and loss of interest.
The current depressive episode, which is the period of time the person has been experiencing these symptoms, must have lasted no longer than 12 months.
The person must have a MADRS score of 22 or higher at the start of the study. The MADRS is a scale used by doctors to measure the severity of depression symptoms.
The person must provide written consent, which means signing a document agreeing to take part in the study.
The person must be willing to start a new, standard antidepressant medication chosen by their doctor to be taken alongside the study drug.
The person must be willing to stop any current antidepressant medication if the doctor decides it is not working. This may involve a tapering process, which means slowly reducing the dose, or an immediate stop, followed by a wash-out phase, which is a period of at least 7 days without any medication.
Male participants with a partner who can become pregnant must agree to use barrier methods of birth control (such as condoms) or practice sexual abstinence (not having sex) from the time they sign the consent form until 28 days after their last dose of the study medication.
Women who are able to become pregnant must agree to take pregnancy tests and use highly effective birth control, such as hormonal methods, an intrauterine device (IUD), or practice sexual abstinence, from the time they sign the consent form until 28 days after their last dose of the study medication.

Who Cannot Join the Study?

You have a known hypersensitivity (an allergic reaction) or intolerance (the body cannot handle) to ketamine or any of its excipients (inactive ingredients used to make the medicine).
You have hypertension (high blood pressure) that is not being treated or is not under control.
Your liver function (how well your liver works) is impaired, which is shown by high levels of certain chemicals in your blood such as GGT, ALP, ALT, AST, or bilirubin.
You have hepatitis B or C (infections that cause liver inflammation).
You have kidney problems, which are identified by a low eGFR (a measure of how well your kidneys filter blood), high creatinine levels, or if you are currently undergoing dialysis (a process to clean your blood) or have had a kidney transplant.
You have diabetes mellitus with an HbA1c level (a measure of average blood sugar over time) higher than 64 mmol/mol.
You have hyperthyroidism (an overactive thyroid).
You have hypothyroidism (an underactive thyroid) that is not stable or is not being treated with thyroid hormones.
You have a history of complicated cystitis (a serious bladder infection) within the last 5 years.
You have any other significant illness that the doctor believes might put you at risk or make it difficult to follow the study rules.
You have previously used ketamine or esketamine, except if it was used for anesthesia during surgery.
You are pregnant, breastfeeding, or planning to become pregnant.
You are taking any prohibited medications or treatments that are not allowed during this study.
You have a history of alcohol use disorder or substance use disorder (addiction to drugs like benzodiazepines, opiates, hallucinogens, or stimulants) within the last 6 months, or you have tested positive for drug abuse.
You are already participating in another clinical treatment study.
You are currently receiving electroconvulsive treatment (ECT) (using electricity to trigger seizures) or repetitive transcranial magnetic stimulation (rTMS) (using magnets to stimulate the brain).
You are under compulsory psychiatric care (required legal mental health supervision).
The doctor believes you may be unable to finish the study, such as through non-compliance (not following the study instructions).
You have started psychotherapy (talk therapy) in the last 6 weeks or plan to start it during the study.
You are considered to have a high suicide risk.
You have certain psychiatric or neurological conditions, including severe depression with psychotic features (losing touch with reality), schizophrenia, bipolar disorder, or personality disorders.
You have close family members (parents, siblings, or children) with psychotic or bipolar disorders.
You have neurodevelopmental disorders, such as autism spectrum disorders or intellectual developmental disorders.
You have a history of brain surgery, encephalitis (inflammation of the brain), meningitis (inflammation of the membranes covering the brain), epilepsy (seizure disorder), or any other major injury to the central nervous system (the brain and spinal cord).
You have had a serious head injury within the last 2 years.
You have had a cerebrovascular event, such as a stroke or a transient ischaemic attack (a temporary blockage of blood flow to the brain).
You have ongoing cardiac disease (heart disease), such as congestive heart failure or tachyarrhythmia (an irregular or fast heartbeat).
Your electrocardiogram (a test that records the electrical activity of your heart) shows abnormal results that might make participating unsafe.

Where you can join this trial?

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Site Name	City	Country	Status
Region Skane	Malmo	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.03.2026

Trial locations

Ketamine is a medication taken as a tablet that is designed to release into your body slowly over time. In this study, it is being tested as an extra treatment to help support the effectiveness of standard antidepressant medicines for people experiencing major depression.

Investigated diseases:

Major depression

Major Depressive Disorder – This condition is a mental health disorder characterized by persistent feelings of sadness and a loss of interest in activities once enjoyed. It often involves changes in energy levels, sleep patterns, and appetite. The symptoms can interfere with a person’s ability to function in daily life. Over time, the symptoms may fluctuate in intensity or become more frequent. The condition can also affect a person’s ability to concentrate or make decisions.

Trial ID:

2025-524841-28-00

NCT ID:

NCT07396272

Trial Phase:

Therapeutic exploratory (Phase II)

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A study of ketamine hydrochloride as an additional treatment for patients starting standard antidepressants for major depression

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?