Study Information: Treatment-Resistant Depression
Depression is one of the most common mental disorders in the United States.
One form of depression – major depressive disorder (MDD) – is defined as a period of two weeks or longer during which there is either depressed mood or loss of interest or pleasure, along with other symptoms such as problems with sleep, eating, energy, concentration, and self-image. Major depression is estimated to affect as many as 16 million adults – nearly 7% of all people over 18 – in the U.S. Many excellent medicines have proven effective in treating depression, yet there are some people who have tried several medications but have not had their symptoms improve. These people are said to have Treatment Resistant Depression (TRD), the disorder being studied in this clinical trial.
This clinical study is sponsored by Axsome Therapeutics.
Axsome wants to determine whether an investigational medication (also called a study drug or compound, not yet reviewed by the FDA) will safely and effectively help improve symptoms of depression in adults who have not had success with other antidepressant therapies. The study will compare the study drug to a medication approved by the FDA for treatment resistant depression.
Finger Lakes Clinical Research (FLCR) is one of approximately 50 sites in the U.S. selected by Axsome to conduct this study. Dr. Sarah Atkinson is the principal investigator (PI) for this trial. She is a board certified psychiatrist with over twenty years’ experience in the field of central nervous system disorders.
How is the study conducted?
Participants will come to Finger Lakes Clinical Research (at Twelve Corners in Brighton) six times over a period of about 14 weeks. The first part of the trial is a screening period, which will include medical examinations and tests, and questionnaires about medical and psychiatric history. In the second part of the trial, participants will take the currently-approved medication for 6 weeks. And in the final part of the trial, half the participants will continue with that medication, while half will be given the study drug. This is a “double-blind” study, so neither the participant nor the study team will know who is continuing with the first medicine and who is taking the study drug.
There is no cost to participate, and no insurance is required. Study participants are paid a stipend for time and travel for each visit.
Do you qualify for this study?
Every clinical study requires that participants meet certain criteria. Dr. Atkinson will make a medical determination as to whether you are able to participate, but you can get a quick idea of whether or not you might qualify by answering these three questions: