Clinical research studies are designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing medications. Studies are important for medical research advances. Current treatments for diseases and conditions are only available because of study volunteers.
Learn more about clinical studies at: www.nimh.nih.gov/health/trials/index.html
An investigational medication is a substance that is being tested in clinical research studies and may or may not be approved by the Food and Drug Administration for treatment of this condition.
A placebo looks like the investigational medication but has no active medication in it. Researchers compare the results of the investigational medication to those of the placebo.
Research studies are typically conducted by a trained medical professional. An Institutional Review Board (IRB) reviews all research studies. This is a committee made up of doctors, ethicists, and members of the general public and administrators. This group helps to ensure that the rights of research participants are protected. A participant’s regular doctor is responsible for their well-being and they may want to speak with their doctor before agreeing to participate in a study as there are possible risks associated with participation. Whenever someone agrees to enter a study, they are given the name and telephone number of a contact in their study physician's office who will answer their questions as well as a contact for the institutional review board overseeing the study, whom they can contact if they have questions or concerns.
If someone has been diagnosed with depression, are currently experiencing symptoms (sometimes referred to as a depressive episode), and are between the ages of 18-65 years, they may be eligible to participate as a volunteer in one of the studies in the RELIANCE Clinical Research Program.
The RELIANCE Clinical Research Program includes studies for people who are currently taking antidepressants but find that they are not fully managing their symptoms. If they were in one of these studies, they would continue to take their current antidepressant in addition to using the investigational medication.
The studies in the RELIANCE Clinical Research Program have two groups (investigational medication and placebo) and may last up to ten weeks. This time includes a screening period, a treatment period, and a follow up period. Participants can stop their participation in the study at any time.
In the open label study, all participants will receive the investigational medication for up to 1 year.
Participants will visit the study team 6 times during the treatment period.
No, they will continue to take their current antidepressants while participating in this study.
For all studies in the RELIANCE Clinical Research Program, participants will be expected to take the investigational medication (or placebo) by mouth once a day for 28 days during the treatment period. Lab tests, a physical exam, and other assessments and questionnaires will be conducted at study visits, but not all activities will occur at every visit.
Some study participants may enter a 14-day follow-up safety period without the investigational medication, during which time they will visit their study team 4 more times over a 14-day period, up to a total of 10 visits. Additionally, they may have the option of enrolling in a one year long-term open label study, during which all participants will receive the study medication, even if they received placebo during the study.
Participants do not have to pay for participation in a clinical research study. This includes the investigational medication, study supplies, study visits, or any tests that are part of the study. They may receive reimbursement for their time and travel.
There are possible risks involved with any clinical research study. The study doctor will review the risks with participants, and they will be closely monitored throughout the study. They may experience side effects and be uncomfortable, the investigational medication may not work for them, or it may not be better than their current treatment, and they may not be part of the treatment group that gets the investigational medication.
Confidentiality is an important part of clinical research studies. Their personal information will be seen only by those authorized to have access.