- Male or Female 18-65 years old
- Generally healthy
- May or may not be taking medication to treat bipolar, but still have bothersome symptoms
Why participate in clinical research? Here are just some of the benefits:
Access to potentially more effective treatments before they become widely available
Study-related medications, tests, and procedures free of charge
A lot of personal attention from doctors, research coordinators, and other members of the BCT team
Compensation for participation, free transportation, meals, and childcare at the time of your visits may be available
Participating in clinical trials at BCT is an important decision. We depend on people like you to make new medications available. Please read what other people think about their experience with BCT.
"BCT made me feel welcome. They even sent a cab for me!”
"I look forward to my visits to BCT. From doctors to receptionists, everybody is always friendly and supportive."
"My experience with BCT has been great. The coordinators REALLY listen”
Bipolar disorder (formerly called manic-depressive illness or manic depression) is a mental disorder that causes unusual shifts in mood, energy, activity levels, concentration, and the ability to carry out day-to-day tasks.
There are three types of bipolar disorder. All three types involve clear changes in mood, energy, and activity levels. These moods range from periods of extremely “up,” elated, irritable, or energized behavior (known as manic episodes) to very “down,” sad, indifferent, or hopeless periods (known as depressive episodes). Less severe manic periods are known as hypomanic episodes.
Bipolar disorder is typically diagnosed during late adolescence (teen years) or early adulthood. Although the symptoms may vary over time, bipolar disorder usually requires lifelong treatment. Following a prescribed treatment plan can help people manage their symptoms and improve their quality of life.
People with bipolar disorder experience periods of unusually intense emotion, changes in sleep patterns and activity levels, and uncharacteristic behaviors—often without recognizing their likely harmful or undesirable effects.
People having a manic episode may:
People having a depressive episode may:
A clinical trial is medical research to study the safety and effectiveness of an investigational drug or device. The US Food and Drug Administration (FDA) uses information gathered in clinical trials to evaluate medications before approving them for use in the United States.
Our professional staff consists of physicians, registered nurses, and clinical research professionals.
Before you are evaluated as a research participant, we will provide you with an approved Informed Consent Form (ICF) which you must read, understand, and sign before enrolling. The ICF outlines all procedures you will need to go through and all known risks and side effects of the investigational medication. Please read it carefully and ask all questions you might have.
Additionally, both FDA (www.fda.gov) and National Institute of Health (www.ClinicalTrials.gov ) maintain databases of clinical trials conducted in the US. All trials conducted by BCT are registered with FDA. If you need help finding information about a trial that you’d like to learn about, please do not hesitate to ask our staff.
In most studies, participants receive monetary compensation for participation in the study. The amount of compensation is set by the study Sponsor (the company conducting the research on the investigational drug or device) and is approved by Institutional Review Boards (IRBs). The exact amount you will receive per visit will be shown in the Informed Consent Form. Additionally, in some studies you may be offered transportation to and from appointments, meals, and childcare at the time of your visits.
Before conducting a clinical trial, pharmaceutical companies must obtain approval from the FDA to ensure that the investigational medication is appropriate to give to people.
Additionally, all study procedures are reviewed by an independent Investigational Review Board (IRB) before they are allowed to be administered. All this is done to ensure that the study is ethical and that the risks are as low as possible. However, since the study participants are among the first to try the investigational medication, the risk of unanticipated side effects does exist. This is why the health of the people participating in the trials is continuously monitored and any serious side effects experienced by any of the people in the trial are promptly investigated. If necessary, corrective actions, including termination of the trial, are taken.
Different studies have different enrollment requirements. Some studies are open only to healthy adults, other look for people with specific medical conditions, for instance, anxiety, depression, migraines, sexual dysfunction, etc. To determine whether you can enroll, we will ask several questions about your current health, your medical condition, and the medications you are taking. If you meet the study requirements, an appointment will be schedule for you to be evaluated in person.
Below is the typical process for a clinical trial:
Of course. Your participation in a research study is entirely voluntary, and you may withdraw from participation at anytime and for any reason. During your screening visit and throughout the study, we will fully explain the risks and benefits of your study. If you change your mind, you may withdraw.
You can register to be part of our volunteer database here and we will get in touch with you if you may qualify for a study.
Never. Any information you provide as a research participant is strictly confidential. It will not be sold and will be used only for the purposes of contacting you for relevant research studies.
Prior to Enrollment: