Major Depression - Gaithersburg MD (Clinical Trial # 21433)

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City: Gaithersburg
State: MD
Zip Code: 20877
Study summary: Not everyone’s depression is the same.

It’s not easy to manage the feelings of sadness, hopelessness, and frustration caused by major depressive disorder (MDD). Clinical research studies like the MOSAIC clinical research study are conducted to evaluate if investigational drugs are safe and effective to treat MDD.

Why is the MOSAIC study being done?

This clinical research study is being conducted to evaluate the safety and efficacy of an investigational drug when taken together with an antidepressant for adults who have MDD.

Who Can Participate?

The MOSAIC clinical research study is for adults with major depressive disorder (MDD). You may be eligible to participate if you are:

  • 18 to 65 years old
  • Currently taking an antidepressant

There are other eligibility criteria that you must meet to be in the study. If you qualify for further screening, the study doctor will review all eligibility criteria with you.

How long will the study last?

The study will last for about 19 weeks. You will need to visit the study doctor’s office about 13 times.

What will happen during the study?

If you meet the requirements to join the study, the study doctor will prescribe an FDA‐approved antidepressant medication that you will continue to take during the study in addition to the study drug.

During the first 8 weeks of the study, you may receive a pill that has no active study drug in it (placebo) to take with the antidepressant. After 8 weeks, you may continue to get placebo or get the investigational study drug depending on how you respond to the antidepressant.

You will be randomly assigned to receive the investigational study drug or placebo (no active drug). You will have a 1 in 2 (or 50 percent) chance of receiving placebo. The investigational study drug and placebo are capsules that look exactly the same. You will have to take one capsule of your assigned study drug once a day by mouth.

At the study visits, your vital signs will be measured, you will be asked how you are feeling, and you will have procedures such as blood and urine tests.

Why should I consider participating?

Participating in the MOSAIC clinical research study is voluntary. This study may help doctors learn about the investigational study drug and how it affects adults with MDD. The study and your participation may help doctors develop more treatment options for adults with MDD in the future.

Before choosing to participate in the study, you should read all the information the study doctor provides and ask questions about the study. The study doctor can answer any questions you may have about study procedures, potential risks and benefits of study participation, and other treatment options for your depression.

To see if you may qualify, complete the study questionnaire.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials or take the Participation Quiz to find out if you are a good candidate for clinical trial participation.

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