MOONLIGHT-1 Depression Research Study
We strive to unveil brighter paths towards healing.
The purpose of this study is to evaluate an investigational medication’s effect on depressive symptoms.
Study doctors want to compare the investigational medication to placebo, which looks like the investigational medication but contains no active medication.
The investigational medication has not been approved by regulatory health authorities for the treatment of depression.
It is only available to patients in research studies like this one.
The results of this study will provide more information about the investigational medication. Study doctors and health authorities may learn more about whether the investigational medication could one day be given to people with depression.
Major Depressive Disorder (MDD) is a serious mental illness that negatively affects how a person feels, thinks and acts. Globally, an estimated 5% of adults suffer from depression, approximately 280 million people in the world have depression.1
If you are eligible for this study and agree to participate, you will be asked to stop taking any antidepressant medication for at least 2 weeks prior to beginning the Study Treatment Phase.
After this period, you will go through the following phases (in this order):
Study Treatment Phase (lasts 2 weeks):
- You will be randomized (like drawing numbers out of a hat) to receive the investigational medication or placebo
- You have a 50% chance of receiving the investigational medication and a 50% chance of receiving placebo
- You will take your study medication (investigational or placebo) once daily before bedtime for 2 weeks
- You and the study doctor/staff will not know which study medication you are taking
- In the event of an emergency, this information can be provided
- You will also not be allowed to take certain medications
Observational Phase (lasts 2 weeks):
- You will not take any study medication
- You will also not be allowed to take certain medications
Standard of Care Follow-Up Phase (lasts 6 weeks):
- You will not take any study medication
- The study doctor and/or your personal doctor can arrange for you to take antidepressant treatment(s) during this time
During these phases, you will have regularly scheduled study clinic visits and phone or video calls with the study doctor/staff.
Your total study participation may last up to 18 weeks (about 4.5 months).
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