Still feeling SYMPTOMS OF DEPRESSION despite taking prescription medication?
You may be eligible for a new research study exploring an innovative potential treatment option.
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About the SOLEO Study
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 sufficient for them.
The SOLEO study is currently enrolling subjects suffering from major depressive disorder and is designed to assess the safety and efficacy of the study drug for people who have tried other treatments for major depressive disorder without sufficient improvement.
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 sufficient for them.
The SOLEO study is currently enrolling subjects suffering from major depressive disorder and is designed to assess the safety and efficacy of the study drug for people who have tried other treatments for major depressive disorder without sufficient improvement.
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Study Drug Information
In this research study, we are evaluating a drug called CLE-100. It is a tablet taken once daily in addition to your 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 all participants will be offered the opportunity to receive the active study drug (CLE-100) for a period of 6 months at no cost.
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 all participants will be offered the opportunity to receive the active study drug (CLE-100) for a period of 6 months at no cost.
Study Overview
The SOLEO study consists of several key phases:
1. Consent
2. Screening
3. Double-Blind Study Treatment Period
4. Optional Extension
Are You Eligible?
To join this study, potential study participants:
- Must be 18 to 65 years of age
- Must be currently experiencing a depressive episode
- During the current depressive episode, must have tried at least 2 (but no more than 5) antidepressants that did not provide adequate relief to the depression symptoms This is not a complete list of study requirements. The staff at the study clinic will explain the complete list of requirements.
Costs and Expenses
- There is no cost to participate.
- Compensation will be provided for completed visits for participant's time and effort and for travel to and from study visits.
Risks and Benefits
- All drugs and medical procedures carry a risk of side effects. Therefore, it is possible that participants may experience some discomfort or other reactions from the use of CLE-100 or from the study procedures or tests.
- The study staff will explain these risks before potential participants decide whether to participate in the study.
- The safety of participants will be closely monitored throughout the study.
- Participants will help contribute to the testing of CLE-100 and the information learned from this study may help find treatment options in the future for people who suffer from depression.
- There is no guarantee that study participants will receive any direct benefit from their participation.
Ready to Take the Next Step?
Complete our quick pre-screening questionnaire to see if you qualify.
