Continuing to experience the effects of depression

Location trial

Gender Both
Age 18 up to and including 74
BMI 18 up to and including 40
Calculate your BMI here

CONTINUING TO EXPERIENCE THE EFFECTS OF DEPRESSION

Participate in a research study for adults who have depression.

What is the OARS 7 Study?

This clinical research study is testing an investigational medication to see if it is safe, is effective, and how long its effects last. The investigational medication is being studied in people with depression. Participants will continue taking their current antidepressant, and either the investigational medication or a placebo (a treatment that looks like the investigational medication but doesn't contain any medicine) will be added to their current treatment regimen. This study is for people whose current antidepressant hasn't fully improved their symptoms.

The safety and efficacy of the investigational compound have not been established, and it has not been approved by any Regulatory agencies.

Who can take part?

You might be able to join this study if:

You are between 18 and 74 years old.
You have been diagnosed with depression.
You have tried an antidepressant before that didn’t work well.
You are currently taking an antidepressant but still have symptoms of depression.

The study doctor will talk with you about other requirements to see if you qualify.

What happens if you decide to participate?

The study has two parts: Part 1 and Part 2.

Part 1 lasts about 3 months.
Part 2 varies in length.

For more details, check the "What can I expect?" tab.

If you qualify for the study:

You will receive study-related medical care and investigational medication or placebo at no cost.
The study will not cover other medical care or medications you need for your regular health care.

How to apply

To learn more about the study and see if you can participate, please register on this website and answer the questions below. If you qualify, someone will contact you to answer your questions and help schedule an appointment.

What can I expect if I join the study?

If you qualify, decide to join the study, and sign the informed consent form, you will attend two screening visits with study staff. These visits include tests, interviews, and procedures to confirm if the study is a good fit for you.

The study has two parts: Part 1 and Part 2.

Part 1:

Lasts up to 10 weeks.
You will be randomly assigned to receive either investigational medication or a placebo (a look-alike with no active ingredients) once a day for 6 weeks.
There is an equal chance of receiving either investigational medication or placebo.
Neither you nor the study team will know which you are receiving.

If you complete Part 1, you can choose to continue to Part 2.

Part 2:

Everyone will receive investigational medication for up to 16 weeks.
After 16 weeks, you may be randomly assigned to continue with the investigational medication or switch to a placebo once a day for the rest of the study.
Like in Part 1, neither you nor the study team will know which you are receiving.

Some Examinations, Tests and Procedures you can expect during this research study:

Medical history (including disease diagnosis)
Physical exam
General health status
Clinical interviews with site staff and with a clinician outside of the site staff
Sleep diary and questionnaires collected on the mobile phone
Telephone interviews
Blood and urine samples
Alcohol breath test
Pregnancy test
ECG (Electrocardiogram)
PSG/PSG-like device (Polysomnogram – Device to provide information from the brain about sleep patterns)

What is the investigational study medication?

The sponsor provides investigational study medication, or a placebo. You will receive a blister pack with pills. You will need to take one pill once per day with water. The study drug must be taken prior to going to sleep.

The safety and efficacy of the investigational medication have not been established ans is not approved for use in any country. It can only be used in research studies like this one, and the results may determine if the investigational medication will be approved by regulatory agencies in the future. This would allow the medication to be made available to patients outside of clinical trials.

Your Current Antidepressant Therapy
You will continue taking your current antidepressant in the usual way you took it before the study.

What is a clinical study?

A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation of an investigational medication or treatment. Clinical trials are conducted by doctors and researchers. Investigational medications have not been approved by Regulatory agencies for the use under which they are being studied.

What happens if you decide to participate?

Clinical research helps doctors and scientists determine if an investigational medication or therapies are safe and/or effective for use in humans to potentially treat a condition, disease, or disorder. Clinical studies often require many volunteers to participate in a single study, and sometimes thousands are needed to obtain reliable information.

What is Informed Consent?

“Informed Consent” is a process of information exchange before an adult agrees to participate in research. Potential research participants will be asked to read and sign an informed consent document, but will also be given instructions, verbally and in writing, question/answer sessions and other reading materials to ensure the potential study participant’s understanding and willingness to voluntarily enroll in the research.

Before you agree to volunteer for the study, the study doctor or staff is required to explain all the details of the study, which will include the potential risks and benefits, and address your questions. After all your questions have been answered, and if you wish to participate, you will then sign a document called the informed consent form to ensure:

You agree to volunteer.
You understand the study, including the study procedures, potential risks, and potential side effects of the study medication.
You understand that you can leave the study at any time, for any reason.

If you don’t understand what is expected of you or the document, you should continue to ask questions and talk with the study doctor, your family, and/or others that you trust, until you feel you understand.

Apply for this trial

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Continuing to experience the effects of depression