Bipolar Depression Clinical Trials | Boston Clinical Trials
Bipolar Depression Study

Are you suffering from bipolar disorder?

This clinical study might be for you.

Participant Requirements

  • Male or Female 18-65 years old
  • Generally healthy
  • May or may not be taking medication to treat bipolar, but still have bothersome symptoms
Register now

Study Benefits

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

Register now

Personal Experiences

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”

More about Bipolar Disorder

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 I Disorder— defined by manic episodes that last at least 7 days, or by manic symptoms that are so severe that the person needs immediate hospital care. Usually, depressive episodes occur as well, typically lasting at least 2 weeks.
  • Bipolar II Disorder— defined by a pattern of depressive episodes and hypomanic episodes, but not the full-blown manic episodes that are typical of Bipolar I Disorder.
  • Cyclothymic Disorder (also called Cyclothymia)— defined by periods of hypomanic symptoms as well as periods of depressive symptoms lasting for at least 2 years

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:

  • Feel very “up,” “high,” elated, or irritable or touchy
  • Feel “jumpy” or “wired”
  • Have a decreased need for sleep
  • Have a loss of appetite
  • Talk very fast about a lot of different things
  • Feel like their thoughts are racing
  • Think they can do a lot of things at once
  • Do risky things that show poor judgment, such as eat and drink excessively, spend or give away a lot of money, or have reckless sex
  • Feel like they are unusually important, talented, or powerful

People having a depressive episode may:

  • Feel very sad, “down,” empty, worried, or hopeless
  • Feel slowed down or restless
  • Have trouble falling asleep, wake up too early, or sleep too much
  • Experience increased appetite and weight gain
  • Talk very slowly, feel like they have nothing to say, forget a lot
  • Have trouble concentrating or making decisions
  • Feel unable to do even simple things
  • Have little interest in almost all activities, a decreased or absent sex drive, or an inability to experience pleasure (“anhedonia”)

Frequently Asked Questions

  • 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:

    • Screening interview – Information will be taken concerning your age, medical history, medications, and other preliminary questions to make sure you meet the study requirements.
    • Informed consent – You will receive materials that fully explain the nature of the study and how you will participate. Our research staff will tell you of any known risks or potential side effects. It is very important that you ask questions and read the consent form carefully. Please ask any questions you might have to fully understand the risks and benefits of your participation.
    • Assessments and medication – Once you are enrolled in a study, you may have a study-related physical exam, receive the study medications, undergo laboratory tests, and other study procedures. During the course of the study, research team members will meet with you regularly to monitor your progress.
  • 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:

    • You have a right to be fully informed about potential benefits and risks of the trial.
    • You have a right to be fully informed about the trial plan, i.e., number and duration of the visits, study procedures, etc.
    • You have a right to voice any concerns and ask any questions you might have about any aspect of the trial.

    After Enrollment:

    • You have a right to withdraw from the trial any time.
    • You have a right to be treated with respect and attention.
    • You have a right for compensation as indicated in the ICF.