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Clinical trials are important to advancing researching and developing new treatments. There are generally three stages of clinical trials for drug development, referred to as Phase 1, Phase 2 and Phase 3. Phase 1 studies are typically done in individuals with a focus on safety. Phase 2 studies often are done to test the safety and effectiveness of different potential doses. Phase 3 studies are the largest type of studies to further evaluate safety and effectiveness of the investigational medicine. Both Phase 2 and Phase 3 studies involve people living with the condition or disease that the investigational medication is intended to treat.
Once all phases are complete, the information can be submitted to the U.S. Food and Drug Administration (FDA) in a large package of information which is then reviewed for safety, efficacy, and considered for potential approval for a specific disease or illness.
To learn more about clinical trials, please visit the National Institute of Mental Health here.
The Reliance Clinical Research Program was initiated following multiple Phase 1 and Phase 2 clinical trials in individuals receiving REL-1017. The safety and efficacy results from these trials support larger trials designed to evaluate the safety and effectiveness of REL-1017 to help the symptoms of depression in people who live with MDD. Please visit our Product Development page to learn more.
The Reliance Clinical Research Program includes studies comparing REL-1017 to placebo over a treatment period of 28 days, either as an adjunctive (or add-on) treatment with a standard antidepressant or as a monotherapy (if not currently taking an antidepressant medication). Participants of the placebo-controlled studies may choose to continue into a long-term safety study. All participants in this long-term safety study will receive REL-1017, and it will continue for at least one year. Participants may also join the long-term study directly, without first participating in a placebo-controlled study.
To learn more about the Reliance Clinical Research Program and if you might be able to participate, please visit reliancestudies.com.