Clinical Trial 38901

Middleburg Heights, OH 44130


Summary:

We know that living with major depressive disorder is never easy. One of the reasons for this is that finding an effective treatment is often difficult.

Many people with depression are prescribed antidepressants that do not provide adequate symptom relief, or only help for a short time. Because symptom relief is necessary to getting the lives of those who suffer from depression back on track, it is important that we continue looking for new and better treatments for depression.

Conducting medical research through studies like this one is how doctors and drug companies like Axsome Therapeutics, Inc. learn new information about potential medications. Participation of study volunteers is an essential part of the process. Please read-on to learn more about this medical research study for adults who are currently experiencing depression and who have tried one or two antidepressants without receiving adequate symptom relief.

 

The Purpose of this Research Study

In this research study, we will evaluate the effectiveness and safety of an investigational drug for adults who have not adequately responded to 1 or 2 previously prescribed antidepressants.

 


Qualified Participants Must:

• Attend visits on routine schedule at our offices in Middleburg Heights, Ohio.


Qualified Participants May Receive:

What to Expect

This treatment resistant depression study will involve up to 10 visits to the study center over a period of about 14 weeks.

During the first visit (the “screening visit”), the study requirements as well as the potential risks of participation will be explained in detail. Those wishing to participate after this explanation will be asked to sign a written consent form. Next, various questions, tests, and examinations will be asked and given to determine eligibility to participate in the study.

All participants enrolled in this depression study will first receive an FDA-approved antidepressant for a period of six weeks. Then, if eligible, the participants will enter a second period of 6 weeks of treatment and either continue to receive the FDA-approved antidepressant or be switched to an investigational drug during one of the visits of the second period.

 

Health Insurance and Participation Costs

Health Insurance is not required to participate.

All medical examinations and assigned study drugs are provided to qualified participants at no cost. Financial compensation may also be provided to cover time and travel expenses related to the research study.


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.