KET01-IIT03: 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
Major depression is a common illness that deeply affects how you feel, sleep, and cope with daily life. Standard antidepressant medicines are often helpful, but they can take several weeks or even months to start working properly. This delay can be very difficult for people experiencing severe symptoms. This early-stage clinical trial is testing a slow-release tablet called KET01, which contains ketamine. It is designed to be taken alongside a newly started standard antidepressant. The main goal is to find out if KET01 can improve depressive symptoms rapidly, specifically within the first eight days. Because this is an 'open-label' study, all participants receive the study medicine, with no dummy pill used. Over about four weeks, the research team will closely monitor improvements in mood, sleep quality, daily physical activity, and anxiety levels, while checking blood samples to assess overall safety and inflammation.
At a glance
What is this study about?
Major depressive disorder is more than just feeling down; it is a serious medical condition that causes persistent sadness, lack of energy, poor sleep, and a loss of interest in life. While existing antidepressants help many people, their biggest drawback is time. They typically take between two and six weeks to provide noticeable relief. During these initial weeks, patients may continue to struggle with debilitating symptoms.
Ketamine has gained attention in recent years for its ability to relieve depressive symptoms much faster than traditional medicines, sometimes within hours or days. However, it is usually given through a drip in a clinic. This trial is investigating KET01, a tablet that releases ketamine slowly into the body. Researchers want to explore whether taking this tablet at home, alongside a newly prescribed antidepressant, can help bridge the gap before standard treatment kicks in.
The trial also looks at the wider picture of mental health. In addition to measuring mood changes, the researchers will track physical activity, sleep quality, and markers of inflammation in the blood. Increasing evidence suggests that inflammation in the body may be linked to depression. By studying these factors together, doctors hope to understand better how ketamine works and whether it can offer a safe, rapid-acting boost to traditional mental health care.
Key takeaways
- Tests a slow-release ketamine tablet (KET01) taken alongside a new antidepressant.
- Aims to find out if depressive symptoms can be relieved within the first week of treatment.
- Open to adults aged 18 and over who have been diagnosed with major depression.
- Involves regular clinic visits, mood questionnaires, activity tracking, and blood tests over 29 days.
- Taking part is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with major depressive disorder and are about to start a new course of antidepressant medication.
Because the study is testing how ketamine works as an 'add-on' treatment, it is designed for people who need to start an antidepressant anyway. Both men and women can take part.
People with certain medical conditions, women who are pregnant or breastfeeding, or individuals with a history of certain other psychiatric or substance misuse issues may not be able to join. The study doctors will carefully review your full medical history before you can be enrolled.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years of age or older?
- Have you been diagnosed with major depressive disorder (severe depression)?
- Are you currently starting, or about to start, a new antidepressant medication?
- Are you able to attend clinic appointments across a 4-week period?
- Are you willing to complete mood questionnaires and provide routine blood samples?
What does participation involve?
Taking part in this study lasts for about 29 days (just over four weeks). During this time, you will take your newly prescribed standard antidepressant along with the study tablet, KET01. You will have regular appointments with the research team at the clinic on days 1, 3, 5, 8, 15, and 29. At these visits, staff will ask you questions about your mood, anxiety levels, and any side effects. You will also have simple physical checks, routine blood tests to look at inflammation, and your sleep and movement may be tracked using special wearable devices or sleep diaries.
Potential risks and benefits
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Common questions
What does 'open-label' mean?
Open-label means that both you and the research doctors know you are receiving the real study medication. There is no placebo (dummy pill) in this study.
Will KET01 replace my regular antidepressant?
No. The study tablet is designed to be an 'add-on' treatment taken together with your newly prescribed antidepressant to help you feel better sooner.
Is the study tablet the same as street ketamine?
No. KET01 is a pharmaceutical-grade, carefully measured medicine formulated to release slowly and safely in the body under strict medical supervision.
Does taking part cost anything?
No, taking part in clinical trials in the UK is free, and the study medication and tests are provided at no charge.
What happens if I decide I want to stop?
You can leave the study at any point without giving a reason. Your doctors will continue to support you and discuss other standard treatment options.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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