Neurobiological Markers of Major Depression in Individuals with Grief.

  • STATUS
    Recruiting
Updated on 15 September 2020

Summary

This study is looking for people over 40 who are grieving the death of a loved one (for example, a partner, sibling, or child), and may or may not be depressed. The study is also looking for healthy people who have not recently experienced a death, as a comparison. The study is intended to identify some of the brain changes associated with depression during grief.

Description

Study schedule
Study-start activities (to be completed over two sessions):
-You will answer questions about yourself and your health.
-You will have a medical / neurological exam.
-You will have assessments of your grief, mood, memory, cognition, and behavior.
-You will give a blood sample. You must fast overnight before the blood sample.
-You will have a brain scan (described below).
The study may end at this point for some participants. Or, based on the results of the study-start activities, some participants may go on to do the activities below:
-You will repeat the memory and cognitive assessments.
-You will repeat the brain scan (described below).
The study will end after about 26 weeks.

Study activities may include
-Answering questions about yourself and your health.
-Having a medical / neurological exam.
-Having assessments of your grief, mood, memory, cognition, and behavior in the form of interview-style conversations, paper-and-pencil questionnaires, computer tests, and/or other activities.
-Fasting overnight before the blood sample is taken.
-Having a sample of blood taken from your arm vein using a needle.
-Having a brain scan (described below).

Treatment or experiment details:
-The brain scan is an MRI. For this, you’ll lie inside the scanning machine for about 1 hour while it takes a 3-D image of your brain.
-There is no treatment being tested in this study.

Additional details:
-You will be compensated for your time and travel expenses.

Details
Condition *Healthy Volunteers
Clinical Study IdentifierTX249209
Last Modified on15 September 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

You could be eligible for this study if
You are between 40 and 90
You are fluent in English
You fit into one of the following categories
You have experienced the death of a loved one. You are grieving, and you may or may not be depressed
You have not recently experienced the death of a loved one. You are healthy and are not depressed
You may not be eligible for this study if
You have a significant medical, neurological, or psychiatric condition, including delirium, seizure disorder, stroke, severe head injury, brain tumor, brain surgery, bipolar disorder, psychotic disorder, psychotic depression, anxiety, post-traumatic stress disorder, suicidality, or dependence on drugs or alcohol
You have dementia of any kind, including vascular dementia
You have significant impairments of your eyesight or hearing, even with glasses or hearing aids
Your study-start brain scan shows brain abnormalities
You take medications that can cause or worsen depression
You have had electroconvulsive therapy in the last 6 months
You cannot have an MRI, for example because of metal in your body
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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