Depressed Mind Study

Did you know that depression in older adults can be difficult to treat and may also be related to memory problems?

 

Are you depressed and feel your memory has gotten worse?

 

While there are many antidepressant medications, they do not always help everyone.  And even with successful depression treatment, memory problems may persist.  There are currently no medicines approved by the U.S. Food and Drug Administration (FDA) that can improve memory and attention in depressed adults.

We are seeking adults age 60 or older who are currently depressed despite receiving standard treatment for depression.

This research study is expanding results from an earlier smaller trial.  It is examining whether nicotine patches may help both depression and memory in older adults.  

You may be eligible to participate if you are depressed and:
  • Age 60 years or older
  • Are currently experiencing symptoms of depression, despite taking a medication to treat your depression
  • Have not used tobacco or nicotine in the last year (distant past use is okay)
  • Do not live with a smoker or have regular exposure to secondhand smoke
  • Have no other mental health diagnoses other than depression and anxiety
  • Do not have a history of alcohol problems or drug use in the last 12 months
What is involved in the study?

Interested people will undergo screening by telephone or internet survey to see if they may be eligible to participate. If you appear eligible and agree to participate, you will complete an initial screening visit to see if you qualify for the study.

The screening visit takes about 2-2.5 hours and will take place at Vanderbilt University Medical Center.  This visit may be able to be completed by video or telemedicine.  At this visit we will gather a medical and psychiatric history, assess your current depressive symptoms, and medication use. You will also complete questionnaires.

After you complete the screening process, you will then have an in-person baseline visit. The baseline visit will last about 4.5 hours and can be spread out over two days if needed. During this visit, you will complete one Magnetic Resonance Imaging (MRI) brain scan, questionnaires, and memory tests.

After the completion of the baseline period, you will then enter the treatment portion of the study. This part of the study lasts about 15 weeks. During this period, you will take study patches and have an in-person visit every 3 weeks. After starting the study medication, you will also complete a total of 4 blood draws, two additional MRI brain scans, questionnaires, and repeat the memory testing once.

Why should I consider participation?

 You will be adding to our understanding of whether this investigational medicine  may help treat depression in older adults, as well as its effects on memory and attention. This information will help us determine if the investigational medication may be a useful approach to treating depression or memory problems in the future.

Will I be reimbursed or compensated?

 Participants will receive monetary compensation for their time and efforts.

 
Frequently Asked Questions
  • Why nicotine?  

    Nicotine stimulates systems in the brain that are important for thinking and memory. The nicotine patch is currently approved by the U.S. Food and Drug Administration for smoking cessation, but it may also benefit other conditions, like memory loss. Past work also suggests that nicotine may help treat depression.

    Depressed Mind 2 researchers are specifically studying the potential benefits of nicotine to test whether it can improve or alleviate the symptoms of memory impairment in older adults with depression.
    What is nicotine?   Nicotine is most commonly known as an ingredient in cigarettes, but it may also have medicinal benefits. When not associated with smoking, researchers believe nicotine can stimulate brain systems associated with memory and attention and can be used to treat memory impairment in late-life depression.
    Is this study supported by the tobacco companies?   No. This study is supported by the National Institutes of Health (NIH).
    Where can I find out more about the results of your past study with nicotine?   Please click here to read more about our previous study.
    Doesn't nicotine cause cancer?   Nicotine does not cause cancer. Fifty years of public health messaging has been instrumental in helping people understand that smoking is detrimental to your health and may cause cancer, however nicotine is not to blame. It's the tar and thousands of other chemicals found in cigarettes that make smokers susceptible to cancer, heart disease, and respiratory issues. A small amount of nicotine absorbed through a patch on the skin is not the same as inhaling tar and other chemicals through the lungs while smoking.
    Isn't nicotine addictive?  

    Researchers have used nicotine in memory studies for more than 30 years. 

    There appears to be no or a very small risk of dependency or addiction when using the nicotine patch to treat mild memory loss or mild cognitive impairment (MCI). In earlier studies, researchers used the nicotine patch to treat MCI in non-smokers, and there were no signs of withdrawal symptoms or cravings after stopping use of the patch. In this same study, participants using nicotine patches showed more improvement in attention and memory loss than those using the placebo patches containing no nicotine.
    Does the nicotine patch have side effects?   All medications can cause side effects, but most people have no, or minimal, side effects when using the nicotine patch in memory studies. If they occur at all, the most common side effects are nausea, dizziness, and headaches. An important part of the screening process is to review your medical history and current medications to determine whether this study is right for you.
    What if I recently stopped smoking or live with someone who is a smoker?   Because of the investigational medication being used for this study, you must not have used tobacco or nicotine in the last year. You must also not live with someone who is a smoker, or have regular exposure to second hand smoke.

    If you are currently a smoker, have been a nonsmoker for less than a year, live with someone who is a smoker, or have regular exposure to secondhand smoker we may have other studies you could be eligible for. Please see the other studies listed on our website or click here to go to our contact information. We are happy to discuss our studies that are currently recruiting with you.

     

  • How long will my participation in the study last?   The screening visit and baseline visit will be completed within about 4 weeks of each other. If you baseline visit is spread out over two days, the visits must occur within 7 days of each other.

    Following the baseline visit, your participation in the study will last about 15 weeks.
    Will I receive results from my study?   We will notify you if there are any clinically important findings.
    If I am experiencing symptoms of depression, do I have to already be diagnosed with depression to participate?   You need to be taking an antidepressant medication to participate in this study. An assessment will be done at the screening visit to determine if you are eligible for the study.
    If I have a history of depression, what if I'm not currently experiencing symptoms of depression?   For this study, we are only enrolling people who are currently experiencing depression. If you have a history of depression but are currently doing well and not depressed, this may not be a good study for you. However we may have other studies you could be eligible for. Please see the other studies listed on our website or click here to go to our contact information. We are happy to discuss our studies that are currently recruiting with you.
    What if I have other mental health problems?   Individuals with a history of Bipolar Disorder, Post-Traumatic Stress Disorder (PTSD), Obsessive Compulsive Disorder (OCD), and Schizophrenia are not eligible at this time. People with anxiety are potentially eligible.
    Will I have to stop taking my current antidepressant medication(s)?   No. You will continue taking your currently prescribed antidepressant medication(s) for this study.

    If you do not want to continue taking your current antidepressant medication(s) for the duration of this study, we may have other studies you could be eligible for. Please see the other studies listed on our website or click here to go to our contact information. We are happy to discuss our studies that are currently recruiting with you.
    What if I don't want to take an investigational medication?   All currently depressed participants will take an investigational medication for this study. We may have other studies you could be eligible for that don’t involve investigational medications. Please see the other studies listed on our website, or click here to go to our contact information. We are happy to discuss our studies that are currently recruiting with you.
    Are there medical conditions that would exclude me from participating?   Yes. Participants cannot have a history of:

     

    • Major neurological disorders, such as dementia, stroke, brain tumors, seizures, Parkinson's Disease, or Multiple Sclerosis (MS).
    • Surgical implants that send electrical signals, such as pacemakers, cardio defibrillators, and spinal cord stimulators.

    There are also certain medications that are not allowed for this study. A study coordinator and/or study doctor will discuss with you all of the medications you are currently taking to see if you are eligible for this study.

     

    What if I don't live close to Vanderbilt University Medical Center?  

    Volunteers must be able to attend study visits at VUMC. Unfortunately, travel reimbursement is not available.
    How can I volunteer?   If you are 60 or older, click here to go to our contact information.
  • What does an MRI involve?   An MRI scan is performed in a large machine that is shaped like a tunnel. This scan does not use x-rays. Instead, they use a strong magnet and radio waves, like those used in an AM/FM radio, to make pictures of your body. We do not give you any drugs or injections for our scan.

     

    Are there any known risks of an MRI scan?  

    There are no known major risks with an MRI scan, although it is possible that you may be bothered by being placed in a tight space (claustrophobia) or by the noises made by the magnet during the scan.

    Before you can complete an MRI for the study, we will take a detailed medical and surgical history to assess you for MRI safety.
    Do I have to be able to have an MRI?  

    MRIs are required for this study. Currently depressed participants will complete 2 MRIs over the course of the study, while those without a history of depression will complete 1 MRI.
    Can I be sedated during the MRI scans? No, sedation is not permitted during the MRIs. We need participants to be awake so they can complete tasks in the scanner.
    I have metal implants. Are these safe for the MRI? Many medical implants are MRI-safe. During the screening visit, we will evaluate you for any surgical implants that may exclude you from having an MRI.

  • We are following all appropriate public health guidelines during the COVID19 Pandemic. We are going to be pre-screening people by phone. Once we have your information, it will be provided to the study doctor to review. We will then reach out to you via email or phone and discuss with you further screening activities.

    For more information about our safety guidelines, please click here.

    To visit the VUMC Coronavirus website, please click here.

  • The Laboratory of Affective and Cognitive Imaging is located within the Center for Cognitive Medicine at the

    Vanderbilt Psychiatric Hospital

    1601 23rd Ave South

    Nashville, TN 37212

     

  • If you have any additional questions or would like to find out if you may be eligible, please click here to be taken to our contact information.