Frequently Asked Questions

BD-D is characterized by periods of intense sadness, hopelessness, and loss of interest in activities, similar to major depressive disorder, but occurring within the context of bipolar disorder.

Signs may include:

• Persistent low mood
• Fatigue
• Change in appetite
• Sleeping much more or much less than usual
• Feelings of worthlessness
• Difficulty concentrating or making decisions

Individuals with BD-D may also experience irritability, restlessness, and racing thoughts, which are attributable to manic or hypomanic episodes, creating a mixed mental state.^1.

You may consider applying for a bipolar depression clinical research study if you or a loved one:

• Are between the ages of 18 – 70
• Have an existing diagnosis of bipolar disorder with depression (BD-I or BD-II) and are currently depressed
• If taking a mood stabilizer and/or atypical antipsychotic for a period of 6 weeks or more, have not had any dose modifications in the past 2 weeks
• Are willing to comply with all study assessments and procedures
• Are not pregnant or breastfeeding

The information gathered in clinical studies may help identify new treatment options in the future for people living with bipolar depression. Study participants are often connected to specialists who understand their situation and can help answer questions from patients or their loved ones. Participants in research studies should expect to experience a professional clinical environment, be treated with compassion and respect, and have access to top quality care during the clinical trial.

Most clinical trials will first involve frontline screening to confirm that a potential patient is, in fact, a match for that study’s criteria. Once verified and the patient has signed an Informed Consent Form, which clearly provides the details and purpose of the study to that individual and what it involves, participants should expect to attend scheduled appointments at a clinician’s office. They will also receive a prescribed medication (called an investigational treatment or study drug), and undergo additional screening and regular follow-up monitoring from a clinician and/or research staff. Throughout the study, participants should experience a professional clinical environment, and be treated with compassion and respect.

There is no cost to participate in a clinical trial. Participants receive all study-related medical care and medications for the duration of the study at no cost. Likewise in many instances, participants may also receive reimbursement for time and travel.

As all drugs and medical procedures carry a risk of side effects, the possibility that participants may experience some discomfort or other reactions during or after a clinical trial does exist. The study staff for that trial will explain these potential risks before participants decide whether to participate, and help address any concerns.

No. Requirements or eligibility criteria vary by clinical trial, and sponsors/clinical sites are constantly looking for patient populations in order to test the efficacy and safety of their investigational drugs. Further screening (phone call, electronic health record retrieval, on-site visit) is often used to determine whether a patient is eligible to participate in an active clinical study, but if not, they will likely be a candidate for one in the future, in which case that person may be contacted.

Yes. Participation in a clinical research study is completely voluntary, and you may withdraw from a clinical research study at any time for any reason and with no penalty to you.

If you are interested in learning more, please contact us at any time. You may email us at help@clinicalenrollment.com.