The X-NOVA study is a clinical trial for people diagnosed with moderate to severe major depressive disorder (MDD), also known as depression. The X-NOVA study will test a new investigational drug called XEN1101 to learn if it can improve depressive symptoms in adults with MDD. To learn more about XEN1101, visit the Study Drug page.
Study participants may be able to join the X-NOVA study if they meet the following requirements:
- 18-65 years of age
- Confirmed diagnosis of moderate to severe major depressive disorder (MDD)
- Currently experiencing a depressive episode
* Other study requirements will apply
Participation in the X-NOVA study lasts a total of about 14 weeks (3.5 months). Participants have a 2 in 3 chance (66.6%) to receive the study drug. The other one-third will receive a placebo (no active ingredients). Study participants can expect the following:
- Informed Consent Form: Review & sign the Informed Consent Form (ICF)
- Confirm study requirements: You will receive study assessments to confirm if you qualify for the X-NOVA study. This is called Screening and will take up to 4 weeks.
- Be assigned to a study group: If you qualify, you will be assigned by chance to either a study group that receives the study drug or to a study group that receives a placebo. Neither you nor the study clinic staff will know which you are receiving.
- Take study drug or placebo: You will be randomized to take either the study drug or placebo once daily for 6 weeks. You will visit the study clinic 5 times during this period and use a wearable device to track sleep and activity levels.
- Complete follow-up: After your last dose of the study drug or placebo, you will visit the study clinic 2 times over the span of 4 weeks for assessments and answer questions in a daily diary.
Participation in a clinical trial is voluntary. You can ask any questions you have and may leave the X-NOVA study at any time, for any reason.