Major Depressive Disorder Study: BUOY-1
Major Depressive Disorder (MDD) can significantly disrupt the lives of those impacted by it, yet currently available antidepressant medicines today are not effective enough for many people. New treatment options are needed for people with MDD.
About the BUOY-1 Study
The purpose of this clinical research study is to evaluate the safety and effectiveness of a study medicine [called SPT-300], taken as a once-daily oral capsule, for the treatment of Major Depressive Disorder (MDD) with or without Anxious Distress. This study will involve up to approximately 360 participants from around the world.
In the BUOY-1 study, the study medicine [SPT-300] will be compared to a placebo. A placebo is a capsule that appears identical to the study medicine but contains no active ingredients.
Study participants will be randomly assigned – similar to flipping a coin – to receive either the study medicine or a placebo. Each participant has an equal 50 percent chance of receiving the study medicine and a 50 percent chance of receiving the placebo.
This is known as a “double-blinded” study, meaning neither the participants nor the study staff will know whether the participants are receiving the study medicine or a placebo In case of medical need, the study doctor can promptly identify which treatment a participant is receiving at any time.
Participants, including those in the placebo group, will have the opportunity to receive the study medicine by continuing in a 6-week extension phase following participation in the initial study.
Assignment
Participants will be assigned randomly (by chance, like flipping a coin) to receive either the study drug or placebo. Each participant will have a 1 in 2 (50%) chance of receiving the study drug and a 1 in 2 (50%) chance of receiving placebo.
Treatment
Neither participants nor the study staff will know which treatment they are receiving. This is known as a “double-blinded” study. In case of an emergency, the study doctor will be able to find out which study treatment a participant is receiving at any time.
Trial Extension
All participants, including those in the placebo group, may have the opportunity to receive the study drug by continuing in a 6-week extension to the trial.
About Seaport Therapeutics
Seaport Therapeutics is a biopharmaceutical company dedicated to developing new medicines for patients struggling with neuropsychiatric conditions, such as depression and anxiety, who need more effective treatment options.
To find out more information about Seaport, please visit www.seaporttx.com.
What does study participation involve?
The study is expected to last up to 11 weeks, including a follow-up visit, if necessary. Participants will be scheduled for approximately one visit per week at the study center and one scheduled telephone appointment with the study staff. Treatment will begin within 4 weeks of the initial screening visit, but likely sooner. Additional visits may be scheduled if the study doctor feels it is in the participant’s best interest.
This study is divided into 3 periods:
Screening Period (4 weeks or less)
Participants will attend one visit to the study center during the screening period. During this visit, the study doctor will provide an explanation of the study and address any questions. Those interested in participating will be asked to sign the Informed Consent Form. Then, certain questionnaires, laboratory tests, and procedures will be done to determine eligibility to take part in this study. The study doctor will review the answers and the test results to confirm whether an individual qualifies for the study.
Treatment Period (of 6 weeks)
Participants will make seven visits to the study center and have one telephone appointment during the treatment period. At the study center visits, participants will be given the study medication (SPT-300 or placebo) to take at home. The study treatment will be provided in oral capsule form to be taken nightly at bedtime.
Post-treatment Period
After completing the treatment period, participants will have one of two options:
Safety follow-up period (about 1 week): this includes one visit to the study center to assess the participant’s health following the end of the study treatment.
OR
Extension study (up to 6 weeks): participants may opt to continue in an extension phase, during which all participants – including those previously assigned the placebo group – will receive the study medicine for up to 6 weeks.
If you are facing emotional distress, crisis or suicidal thoughts, please consider using the following resources for immediate support: