• This study investigates the safety and tolerability of the new compound when administered to participants experiencing a current depressive episode (and who also have had episodes of depression in the past).
• All participants will receive the study drug (though the dose will differ for each participant). This means that no drug without an active substance (placebo) will be given in the study.
• The study compound may potentially be used for the treatment of major depressive disorder. Major depressive disorder (i.e. depression) is a mood disorder that is characterized by symptoms such as gloominess, decreased interest in pleasurable activities or activities previously enjoyed, feelings of guilt/worthlessness, lack of energy and sleep disturbances. The study compound affects certain parts of brain cells. This may help prevent negative thinking patterns.
• During your stay an electroencephalogram (EEG) will be done at several timepoints to measure brain activity. During the EEG, small stickers (with sensors) connected to a cap are placed on your head to measure the electrical signals produced by the brain. On some evenings, you will wear this cap while you sleep, along with monitors to measure your heart rate and breathing – together, these are referred to as polysomnography (or PSG).
• Each day (during the stay), we will ask you to fill out questionnaires about your mood, well-being and other psychological aspects.
• Following the medical screening you will have an interview by telephone with a medical professional and a second screening visit during which a psychologist will ask you questions about your mental well-being.

• You are a male or female in good physical health.
• You have a diagnosis (from your family doctor or psychologist)  of major depressive disorder (MDD) / depression and are in a current major depressive episode for at least a 12-week period. In addition you have had at least one previous episode of depression/major depressive disorder in the past.
• You have not taken antidepressants, sleeping pills, tranquilizers or strong painkillers for at least 4 weeks prior to admission. This timeframe is longer (5 weeks) if the antidepressant is fluoxetine.
• You are at least 18 and at most 55 years old when the study begins.
• Your Body Mass Index (BMI) is at least 18.0 and at most 30.0 kg/m2. 
• You are a non-smoker.
• As a female you can only participate if you are not pregnant, not breastfeeding and meet one of the following conditions:
  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
  • You are using a copper intra-uterine device in combination with a condom;
  • You have passed menopause (no periods for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.
  • As a male you can only participate if you meet one of the following conditions:
    • You are using a condom in combination with an additional contraception method used by your female partner;
    • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
    • You are not sexually active according to your lifestyle;
    • You are only sexually active with a partner of the same sex.

Note: You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first administration of the study compound in this clinical trial (counting from the follow up of the previous trial).

To determine if you are eligible to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 10 days (9 nights) followed by a phone call 1 week after discharge. The follow-up visits will take place 2 and 4 weeks after your departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.