Participating in Research:
Frequently Asked Questions

A research study is designed to answer specific questions, sometimes about a drug or device’s safety and its effectiveness.  Being in a research study is different from being a patient.  When you are a patient, you and your personal doctor have a great deal of freedom in making decisions about your health care.  When you are a research volunteer, the Clinical Coordinator and the research staff will follow the rules of the research study (protocol) as closely as possible, without compromising your health.

Clinical research enables doctors and researchers to find new and better ways to understand, detect, control and treat illness. A clinical research study is a way to find answers to difficult scientific or health questions. For example, the study might explore the best ways to treat a particular illness (one drug versus another) or how to counsel people at risk for breast cancer.

All clinical studies are based on a set of rules and procedures called a protocol. A protocol describes the overall purpose of a study and also spells out rules for including or excluding persons as participants in the study.  Additionally, the protocol determines the schedule of tests, procedures, medications, and dosages; and sets the length of the study.

In many clinical trials, one group of patients will be given an experimental drug or treatment, while a control group is given either a standard treatment for the illness, or a placebo (a harmless "fake" drug), or no treatment at all.

In a blind study, participants do not know whether they are getting the drug being tested, or whether they are in the control group. Sometimes, clinical trials are "double-blind" or "double-masked." That means that neither the participants, nor the study staff members know who is receiving the experimental treatment and who is in the control group receiving either a standard treatment or a placebo. Studies are performed in this way so that neither the patients' nor the doctors' expectations about the experimental drug can influence the results.

Clinical studies are critical to finding new treatments and cures for diseases. Carefully conducted clinical research is the fastest way to find treatments that work and that are safe. By volunteering for a clinical trial, you are participating in research that may result in a new treatment for a disease. 

Before you agree to participate in a study, you must be given complete information about the study, known as "informed consent." The informed consent must include information about the purpose of the research as well as possible benefits and risks. The Food and Drug Administration (FDA) provides details about informed consent with the information page: Clinical Trials: What Patients Need to Know (source: fda.gov).   A participant can leave a research study at any time. When withdrawing from the study, the participant should let the research team know that he/she wishes to withdraw. A participant may provide the research team with the reason(s) for leaving the study, but is not required to provide their reason.

Depression is a common but serious mood disorder. It causes severe symptoms that affect how you feel, think, and handle daily activities, such as sleeping, eating, or working. To be diagnosed with a depression episode, the symptoms must be present for at least two weeks.

PTSD is a disorder that develops in some people who have experienced a shocking, traumatic, or dangerous event. It is natural to feel afraid during and after a traumatic situation. Fear triggers many split-second changes in the body to help defend against danger or to avoid it. This “fight-or-flight” response is a typical reaction meant to protect a person from harm. Nearly everyone will experience a range of reactions after trauma, and most people recover from initial symptoms naturally. Those who continue to experience problems may be diagnosed with PTSD. People who have PTSD may feel stressed or frightened even when they are not in danger.

Depression (major depressive disorder) is a common but serious mood disorder. It causes severe symptoms that affect how you feel, think, and handle daily activities, such as sleeping, eating, or working. To be diagnosed with depression, the symptoms must be present for at least two weeks.

Treatment-resistant depression means that your depression is not responsive to usual treatments.  The definition of what makes a depression episode treatment-resistant varies but usually it means having a longer duration depression episode or failure of multiple treatments during the current episode.

Until the recent past the person experiencing depression was directed to either medications or psychotherapy with no rapid-acting benefit expected.  In comparison, while it was well-recognized that electroconvulsive therapy could rapidly reverse life-threatening depression, including an individual refusing to drink or eat, due to the significant side-effects this rapid-action treatment wasn’t a first, second, or in some cases even a third choice.

The recent use and exploration of the preanesthetic ketamine has contributed to opening up the field to consider a range of rapid-acting treatments.  One of these treatments is the classic hallucinogens.  Early studies in terminal cancer patients experiencing depression and/or anxiety were remarkably favorable with over a 60% immediate response rate and sustained decreases in depression and improved quality of life over six months.

This is an active area of research.  A recent clinical trial from Compass Pathways found in a well-powered study an improvement in depression symptoms in treatment-resistant depression.  We do not expect every patient with depression will be responsive to a classic hallucinogen or is an appropriate treatment recommendation, such as those with a history of psychosis.

Currently, we have an open study for Veterans with treatment-resistant depression to further explore the use of these drugs in patients with depression.