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If so, participating in our medical research study may be an option for you.
We understand how important it is for those who suffer from depression to find an effective treatment. Different types of oral antidepressants work in different ways. For reasons that medical scientists do not fully understand, the degree of symptom relief from various oral antidepressants can differ from patient-to-patient. Many patients find that while they get some symptom relief from the antidepressants they have tried, the relief is simply not adequate for them.
The SOLEO study will enroll participants suffering from major depressive disorder and is designed to assess the efficacy of the study drug for people who have tried other treatments for major depressive disorder without sufficient improvement.
In this research study, we are evaluating a drug called CLE-100. It is a tablet taken once daily in addition to current oral antidepressant. The study drug is an investigational therapy, which means it is still being tested in clinical research studies. It has not been approved by the US Food and Drug Administration (FDA) or other Health Authorities to be prescribed for treatment. If you decide to join the SOLEO study, you will be randomly assigned (like the flip of a coin) to receive either the study drug or placebo (no active ingredients) for 4 weeks after which participants will be offered the opportunity to receive the active study drug for a period of 6 months.
To join this study, potential study participants: • must be 18 to 65 years of age • must be experiencing a depressive episode that began at least 12 weeks before the screening visit • during the current episode, must have tried at least 2 (but no more than 5) antidepressants that did not provide adequate symptom relief This is not a complete list of study requirements.