Bipolar I Disorder, (otherwise known as Bipolar Depression), is a serious mental health condition that can cause extreme emotional mood swings. When someone has Bipolar Depression, dealing with emotional highs and lows can cause issues with all parts of their life.
Bipolar I Disorder affects nearly 5.7 million adults in the United States.1 It can have an impact on every part of life; from work-life, to family, and even friendships. The Release Study is researching the effectiveness and safety of a new investigational drug for adults with Bipolar I Disorder (Bipolar Depression). If you qualify and choose to participate may receive an investigational drug being evaluated for its potential to improve the symptoms associated with Bipolar Depression.
You may be eligible to participate if you:
- Are between the ages of 18-65 years old, inclusive
- Have a diagnosis of Bipolar I Disorder
- Have a documented history of at least one manic episode
- A manic episode is a feeling of heightened energy, creativity and excitability often associated with risky behavior or amanic episode with mixed features (quickly switching between mania and depression without recovery, leading to irritability, high energy, racing thoughts or speech, overactivity, and agitation).
* As a study participant, all study-related care will be provided at no cost to you. Qualified participants may be paid up to $50 for each study visit. Qualified participants who complete the study may receive up to $500.
Sign Up
What happens if I sign up? We will match you to a study center location in your area that is participating in this research study or notify you when one becomes available. The study team will then contact you and you may have the opportunity to participate if qualified.
If you think you might like to participate in the Release Study or would like more information about the Release Study or other studies for patients with Bipolar Depression, please enter your information below so we can see if you may qualify and can contact you about the study. Keep in mind that participation is entirely voluntary. If you do decide to take part in the study, you may change your mind about participating at any time.
About Bipolar I Disorder (Bipolar Depression)
Bipolar I Disorder, (otherwise known as Bipolar Depression), is a serious mental health condition that can cause extreme emotional mood swings. Bipolar I Disorder affects nearly 5.7 million adults in the United States.1
Patients with Bipolar Depression spend considerably more time in depressive states than in manic states over the course of their illnesses.2 Those who have been diagnosed with Bipolar I Disorder may experience depression where they feel sad and hopeless for a period of time, usually followed closely by a shift in mood to mania, or hypomania, where they will experience euphoria, be unusually energetic and irritable.
There are various symptoms to be aware of because there are two types of disorders that make up Bipolar I Disorder.
Symptoms of Mania and Hypomania include:
- Increased activity and energy
- Feeling upbeat and jumpy
- Easily distracted
- Poor decision-making
- Decreased need for sleep
Symptoms of Major Depressive episodes include:
- Depressed mood (sadness, hopeless or empty feelings)
- Loss of interest in usual activities
- Changes in weight
- Fatigue or loss of energy
- Feelings of worthlessness
The treatment of Bipolar Depression is challenging, due to the complexity of clinical presentations, which may include mixed symptoms with depression predominating.
The Release Study is researching the effectiveness and safety of a new investigational drug for adults with Bipolar I Disorder (Bipolar Depression).
Frequently Asked Questions
What is a research study?
A research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug – these may include how well an investigational study drug works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
Why are research studies important?
A research study is the process by which new and innovative medications, interventions and treatments are approved and brought to market, so people can live happier and healthier lives. Even over-the-counter medications, such as NSAIDs, you may have used to counteract a headache, have gone through the clinical research study process before it was available at your local pharmacy.
What is the purpose of the Release Study?
The Release Study is researching the effectiveness and safety of a new investigational drug for adults with Bipolar I Disorder (Bipolar Depression) that are currently in a depressive episode.
The investigational drug is an experimental drug. “Experimental” means that the investigational drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA).
What will the Release Study involve?
Approximately 522 adult study subjects in North America, Europe, Japan, and Latin America will take part in this study. If you agree to take part, and the study doctor determines that the study is right for you, it is expected that you will be in the study for about 10 weeks (2.5 months). The study will include about 7 office visits to the study doctor, and 2 telephone calls.
Will I receive compensation?
Qualified participants may be paid up to $50 for each study visit. Qualified participants who complete the study may receive up to $500. Please discuss this with the study team when they contact you.
Is there a cost to participate?
There is no cost to participate in the Release Study. If you qualify, you will receive study-related care throughout the study from a team of experienced doctors and nurses.
What else do I need to consider?
The research team will be able to further assess your eligibility for the study and explain more about what the Release Study will involve. It is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
How far is the study center?
We match you to a study center within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decided you no longer want your information stored, you can opt out and we will delete your details.
About the Release Study
The Release Study is researching the effectiveness and safety of a new investigational drug for adults currently in a depressive episode with the diagnosis of Bipolar I Disorder (Bipolar Depression). If you qualify and choose to participate may receive an investigational drug being evaluated for its potential to improve the symptoms associated with Bipolar Depression.
About 522 participants at study centers across North America, Europe, Japan, and Latin America will take part in this study.
Study participants will receive all study-related care at no cost. Qualified participants may be paid up to $50 for each study visit. Qualified participants who complete the study may receive up to $500.
Who can take part in the Release Study?
You may be eligible to participate if you:
- Are between the ages of 18-65 years old, inclusive
- Have a diagnosis of Bipolar I Disorder
- Have a documented history of at least one manic episode
- A manic episode is a feeling of heightened energy, creativity and excitability often associated with risky behavior or a manic episode with mixed features (quickly switching between mania and depression without recovery, leading to irritability, high energy, racing thoughts or speech, overactivity, and agitation).
Participants will receive study-related care throughout the study from a team of experienced doctors and nurses.
