Individualized Targeting and Neuromodulation of Late-Life Depression (NCT04543773) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Individualized Targeting and Neuromodulation of Late-Life Depression
United States24 participantsStarted 2024-10-01
Plain-language summary
An open-label, single-arm, clinical research study about how to make transcranial magnetic stimulation (TMS), an FDA-approved treatment, more effective for patients with late-life depression using fMRI.
Who can participate
Age range
60 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant must be at least 60 years of age (all genders, races, and ethnicities), and less than or equal to 79 years of age.
. Participant must have a diagnosis of major depressive disorder without psychosis for the past 6 months, as diagnosed by a board-certified psychiatrist
. Must show evidence of being in a current major depressive episode, as indicated by score on QIDS-C of 10 or higher.
Exclusion criteria
. Participant must be fluent in English
. Current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or any other psychotic disorder
. Substance use disorder, abuse or dependence, with active use within the last 3 months
. Legal or mental incompetency, or inability to consent to study
. Unstable medical illness, or hospitalization within 3 weeks of study entry
. Current diagnosis of a neurological disorder or neurocognitive disorder
. Prior neurosurgical procedure
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on measuring brain connectivity in a region called the Anterior Cingulate Cortex — can you explain what that means for me, and whether understanding my own brain connectivity patterns could have any direct benefit for my depression treatment?
2Since this trial is listed as 'active, not recruiting,' it sounds like they're no longer accepting new patients — is there any way to find out if a similar study targeting brain-based approaches to late-life depression is open and might be relevant for me?
3This trial doesn't seem to have a standard phase label, which makes me think it might be more of a research or mapping study than a treatment trial — can you help me understand whether this is primarily gathering data about the brain, or whether participants actually receive a depression treatment?
4Given that this study involves neuromodulation — which I understand means something like brain stimulation — what are the real-world risks I should know about before even considering whether this kind of approach is right for me?
5Would it make more sense for me to try established treatments for my depression first before exploring a research study like this one, or is there a reason my doctor might think a brain-targeting approach could be worth discussing sooner?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.