OPTIMUM Study – Optimizing Depression Treatment in Older Adults

STUDY BASICS

Are you 60 years of age or older and currently depressed? Are you taking an antidepressant, but not feeling any better? If so, you may be able to participate in a research study to help find out which antidepressants are the safest and most effective for older adults with difficult to treat depression. Compensation provided.

STUDY PURPOSE

Many older adults struggle with depression, but antidepressant medications often fail to resolve their symptoms. Symptoms of depression can include feeling sad or hopeless, feeling tired or not having energy, having changes in appetite or activity, having trouble sleeping, and others. Unfortunately, depression that is difficult to treat can lead to decreased quality of life, physical health problems, and even suicide. Researchers think that age-related changes to the brain and body may make antidepressants work differently in older adults than they do in younger people, but more information is needed. The purpose of this study is to help researchers determine which antidepressant medications are the safest and most effective in older adults with difficult to treat depression. All of the antidepressant medications used in this study are FDA approved. The research team will work with the participant’s primary care physician or community psychiatrist to discuss which medication is being recommended. Participants and their doctors can decide whether or not to follow the recommendations.

COULD THIS STUDY BE RIGHT FOR YOU?

• Age 60 and up
• Currently depressed
• Have taken two or more antidepressant drugs for at least 6 weeks each and are still feeling depressed

WHAT PARTICIPANTS CAN EXPECT

Participation lasts up to 18 months. After an initial phone screening, the research team will get in touch with your primary care physician (PCP) or community psychiatrist to ensure that they are willing to collaborate with the research psychiatrist on your care throughout the study. For qualified participants, the study has three steps: During step 1, you will be randomly assigned (like drawing straws) to receive one of three study medications for 10 weeks. Some participants will add a medication to their current antidepressant medication, and some will replace their current antidepressant medication. Research staff will call patients every 2 weeks to ask about any continued symptoms or side effects. During step 2, if your depression symptoms have not gone away, you will again be randomly assigned to receive one of two study medications for 10 weeks. Some participants will add a medication to their current antidepressant medication, and some will replace their current antidepressant medication. Research staff will call patients every 2 weeks to ask about any continued symptoms or side effects. During step 3, you will be contacted by phone every 4 months and asked to complete questionnaires. These assessments will take about an hour. If your depression symptoms went away during step 1 or step 2, it is recommended that you continue taking the medication that made you feel better.