Study Information: Major Depressive Disorder (Takeda)
Millions of people suffer from major 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.
This clinical study is sponsored by Takeda Pharmaceutical.
Takeda is evaluating vortioxetine – an FDA-approved antidepressant medication – to see whether it can be used to prevent relapse in people with recurrent depression. The efficacy of the medication will be compared to that of a placebo, which is a look-alike capsule that contains no drug or active ingredients.
Finger Lakes Clinical Research (FLCR) is one of approximately 60 sites in the U.S. selected by Takeda 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?
During the first part of the study, you will come to Finger Lakes Clinical Research (at Twelve Corners in Brighton) for an initial screening period of up to 21 days. If it is determined that you are qualified and you wish to continue in the study after the screening period, you will begin taking 10mg of vortioxetine daily, for 16 weeks. This is called an “open-label” period, meaning all participants will be given the FDA-approved medication.
After the open-label period, Dr. Atkinson will determine if you are eligible for the second part of the study, which lasts around 32 weeks. If you are eligible and choose to continue, you will be randomly assigned to either keep taking the same dose of vortioxetine, or to begin taking a lower or higher dose, or you may be given a placebo. This is a “double-blind” study, so all of the tablets will look exactly the same, and neither you nor the study team will know which you are taking. You have an approximately 75% chance of continuing to take vortioxetine (in one of the three doses), and a 25% chance of taking the placebo.
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: