If you or a loved one would like to know more about getting involved with the KOASTAL study program, please complete the online survey to see if you qualify.
Exploring the changing tide in managing depression
Join a research study evaluating a potential new investigative treatment for Depression
The KOASTAL clinical trial program is investigating the effects of a study medicine intended to work in a new way to treat adults living with depression (also called Major Depressive Disorder or MDD). This study medicine is being evaluated compared to a placebo to see whether it can improve the symptoms of depression, including feelings of having less interest or pleasure in the things you used to enjoy (this is called anhedonia, pronounced an-hee-doh-nee-uh).
This investigational medicine is being studied for once-daily use in depression and is not currently approved for sale in any country.
Take this short questionnaire to determine if you prequalify.
Challenges in living with depression
- The most common antidepressants prescribed for depression include selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs). However, these medications do not manage depression successfully in all people1
- Current antidepressants do not fully treat anhedonia (feelings of having less interest or pleasure in the things you used to enjoy), which occurs in up to 7 of 10 people with depression2,3
About the study medicine
This once-daily medicine was created to work in a new way on specific pathways in your brain that affect key symptoms of depression, including the feelings of having less interest or pleasure in the things you used to enjoy. This is a new approach designed to work differently than SSRIs or SNRIs.
KOASTAL Study Participation
You may be able to participate if you:
- are 18–65 years old
- have had symptoms of depression for 1–12 months
- are willing to use birth control, and are not pregnant or breast feeding
- are not a cannabis or THC user
- can give consent and can follow study instructions
A study doctor will explain these requirements to you and will evaluate whether you are able to participate before you decide whether to take part. You may also wish to discuss with your doctor.
What to expect in the KOASTAL study
KOASTAL (clinical trial) is studying the potential efficacy and safety of the study medicine in over 900 people with depression. You will receive treatment related to KOASTAL from your study doctor and can continue to receive care from the doctor who usually treats your depression
There are 3 parts to the study:
A screening period of up to 28 days
A 6-week treatment period
A long-term study that you may be able to join if your study doctor finds you are eligible
Part 1
Screening period
Timing: up to 28 days
- You will visit the study doctor’s office, where the study doctor will talk to you and run tests to determine whether you can be in the study
- The study doctor will use questionnaires to understand your symptoms of depression
- You may need to make further office visits during this period, as determined by your study team
Part 2
Treatment period
Timing: 6 weeks
- You will be randomly assigned to 1 of 2 treatment groups. You will not know which treatment group you are assigned to
The Study Medicine is taken as a once-daily pill
- Your doctor will explain how to record each pill you take, so no doses are missed
- During the study, you will visit the clinic 5 times, where study doctors will ask about your symptoms of depression and note any side effects
- You may stop treatment at any time and for any reason
- After 6 weeks of treatment you can choose to:
- finish the study and complete the safety follow up,
- leave the study, or
- be considered for the long-term study
- If you choose to leave the study, you will have 2 final calls with the study team and an eye clinic visit in the 6 weeks after your last pill to check for any side effects
Part 3
Long-term study
Timing: 54 weeks
- If you wish to join the long-term study, a doctor will first check that you are eligible and have completed the 6-week treatment period
- You will visit the study team, who will examine you and use questionnaires to ask about your symptoms of depression
- There is no placebo pill – everyone will take a once-daily investigational study medicine pill for 52 weeks to help doctors understand the effects of treatment over time
- You will visit the study doctor’s office 6 times, and have 4 calls with the study doctor to check your symptoms and note any side effects
- Two weeks after your last pill, the study doctor will call to check for any side effects
- You may stop treatment at any time and for any reason. This would be followed by a visit to the doctor’s office for examination
Where would I go to participate?
The KOASTAL study will take place at locations across the US and Canada. If you would like more information about the study, please sign up online and if you prequalify you’ll be matched to a site near you. If you would like to speak to someone about the study, please call 888-490-1011.
During the KOASTAL study, you will receive all study-related care from a dedicated medical team at no cost. Reimbursement for study-related expenses may be available to you.
Questions about taking part in a clinical study
What is a clinical study?
Clinical studies are essential to determine whether new, investigational treatments are safe and effective for use in patients. When you agree to take part in a clinical study, you may help doctors determine the efficacy and safety of a new treatment for a specific disease. Clinical studies rely on people with a specific disease to help researchers develop new treatments for people that need them.
What support is available to me during a clinical study?
There are rules in place to make sure that the rights, well-being, and privacy of people entering a clinical study are respected. During the study, support is available to provide help and information about the KOASTAL study.
Why should I participate?
There are lots of reasons for taking part in a clinical study. It can give you access to new, investigational treatments, and involve you in the development of therapies that may benefit others. Deciding to participate is a personal decision – get in touch if you think it might be right for you!
What if I change my mind about taking part?
If you decide to participate in the study as a volunteer, you can change your mind and decide to leave the study at any time, whatever the reason.
KOASTAL is studying the potential efficacy and safety of the study medicine in over 900 people with depression.
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1. Gaynes BN, et al. Cleve Clin J Med. 2008;75(1):57-66.
2. Shankman SA, et al. The Different Facets of Anhedonia and Their Associations with Different Psychopathologies. In: Ritsner, MS (ed). Anhedonia: A Comprehensive Handbook Volume I: Conceptual Issues And Neurobiological Advances. Springer, 2014.
3. Ameli R, et al. Peer J. 2014;2:e429.