Bipolar I Clinical Research

Bi-Polar study

About the RELEASE Study

This clinical research study is looking at how safe a potential new medication (investigational medication) is and whether it improves depression for people with bipolar I disorder.

Why is this study important?

Although treatments are available for people with depression and bipolar I, they do not work for everyone, and some people experience undesirable side effects. It is important to look for potential treatment options that may work differently from available treatments.

What will this study involve?

If you take part, you will be in the RELEASE Study for up to 10 weeks (2.5 months). You will need to visit the study center 7 times and have 2 phone calls. You will be assigned, by chance, to receive either the investigational medication or placebo. The placebo looks like the investigational medication but contains no active ingredients.

How this Study conducted?

The study is made up of 3 parts.

Screening period

(up to 3 weeks)

You will visit the study center to see if the study is suitable for you and whether you want to take part.

Study treatment period

(about 6 weeks)

You will visit the study center 5 times for study assessments, and you will have 2 phone calls. You will take the study medication (either the investigational medication or the placebo) once a day. After this period, you may be able to take part in an extension study. All participants will receive the investigational medication (not placebo) in the extension study.

Follow-up period

(about 1 week)

You will visit the study center once for study assessments after you have finished taking the study medication.

FAQS about RELEASE clinical study for bipolar I

What is a clinical research study?

A clinical research study is a medical study that helps to answer important questions about an investigational medication, such as:

  • Does it work?
  • What amount, or dose, may work best?
  • How safe is it?
  • Are there side effects?

All medications must be tested in clinical research studies before they can be approved to prescribe to patients. Without people taking part in these studies, we would have no new medications. Clinical research studies should include all kinds of people, as certain conditions and medications may affect people differently based on their age, sex, gender, and race/ethnicity.

Who can take part?

You, or someone you care for, may be able to take part if you/they:

  • are 18–65 years of age
  • have been diagnosed with bipolar I disorder
  • currently feel depressed.

What else do I need to consider?

  • The study team will explain the possible benefits and risks of the study.
  • If you choose to take part in the study, you can stop participating at any time.
  • A team of doctors and nurses will monitor your health carefully during the study.

How do I get more information?

To find out more, please contact the study team using the information provided here. Study participation is voluntary. By contacting us, you are under no obligation to take part in the study.
Contact: Siyan Clinical Research Release study team by email : or call (707)806-2443 or fill out contact form below in the page.

Contact Us

If you are interested in participating or would like more information, please fill out the form below