There is no cost to take part in the Belcanto Study. Study-related care and investigational medication are also provided at no cost and overseen by a specialized medical team.
Compensation may also be available.
You may qualify if you:
What happens if I sign up?
If you think you might like to participate in the Belcanto Study, or would like more information, please fill out the questionnaire below so we can see if you qualify and can contact you about the study. Keep in mind that participation is entirely voluntary.
If you pass the initial screener, we will match you to a Belcanto Study location in your area or notify you when one becomes available. If there is not a current study for bipolar depression in your area, we may reach out to you in the future via email, phone, or text to share information about new study opportunities that may be a good fit.
Formerly known as manic depression, bipolar disorder is a mental health condition that is marked by extreme shifts in mood and energy.1 People diagnosed with bipolar I or II cycle through periods of elation and high energy (manic phases) and states of persistent sadness and fatigue. Bipolar depression is the depressive phase of bipolar disorder and can also include sleep changes and difficulties concentrating.2
The moods shifts experienced by people with bipolar I or II are intense and serious as they interfere with the person’s life and the way they act and function. Bipolar-related depression is not a passing mood; people experiencing this phase often meet the criteria for major depressive disorder.
Treatment for bipolar depression includes mood stabilizers (e.g., lithium), atypical antipsychotics (e.g., quetiapine), and antidepressants (in combination with a mood stabilizer) to help level out moods, reduce the risk of suicide, and avoid triggering a manic episode. Psychotherapy, including cognitive behavioral therapy and dialectical behavior therapy, also helps patients learn how to regulate their emotions. For severe cases, electroconvulsive therapy (ECT) is also used.4
A clinical research study (also called a clinical trial) is a medical study that helps to answer important questions about investigational medications, treatments, or devices — these may include how well study medications, treatments, or devices work for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
A clinical research study is the process by which new and innovative medications, interventions, and treatments are reviewed and analyzed before being approved and brought to market.
Investigational medications are not yet available to the public outside of a clinical trial setting. Even over-the-counter medications, such as NSAIDs you may have used to counteract a headache, have gone through the clinical research study process before they were available at your local pharmacy.
This clinical trial aims to determine whether the treatment may help reduce symptoms of bipolar-related depression. If the investigational medicine is effective, it may also support other patients experiencing a period of bipolar depression.
The purpose of the study is to test investigational medication to see whether it’s safe and effective for treating periods of depression due to bipolar I or II.
Compensation may be available for time, travel, and/or participation for those who qualify to take part in the studies. You can discuss this further with the study team. There is no cost to participate in these studies. Study-related care and treatments will be provided to you at no cost by a specialized medical team. Insurance is not required to participate.
The research team will be able to explain more about what the Belcanto Study involves, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in the study will not affect your current or future relationships with your doctors.
If you qualify, we will match you to a study site closest to your home. If we are not currently running the study in your area, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decide you no longer want your information stored, you can opt out, and we will delete your details.
The Belcanto Study for bipolar-related depression is looking to enroll approximately 200 adults actively in a bipolar depressive phase across the United States and Puerto Rico. The study’s 26-week treatment period will be followed by a 30-day follow-up and include eight visits to a study site and three visits for eye/vision testing.
You may be able to take part if you: