Pain and Major Depressive Disorder (NCT04556890) | Clinical Trial Compass
RecruitingNot Applicable
Pain and Major Depressive Disorder
United States54 participantsStarted 2023-03-01
Plain-language summary
This study will examine the effects of brain stimulation on pain symptoms associated with Major depressive disorder. This study will enroll 54 Subjects. Study subjects will be asked to complete surveys about their mood and well-being, 2 blood draws, 2 MRIs, 3 electroencephalograms, and receive 30 treatments of blinded transcranial magnetic stimulation. There is no control group as all subjects will receive some form of active treatment. Subjects are required to participate in 30-33 study visits and volunteer 40 hours of their time. Compensation for this study is $150 for completing all study activities.
Who can participate
Age range
18 Years – 75 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:
* All Subjects must be between 18-75 years of age
* Language: Participants must speak English fluently, as demonstrated by verbal skills sufficient to answer questions at a level that assures adequate understanding of the study
* Must have confirmed diagnosis of moderate Major Depressive Disorder (single or recurrent episode), minimum score of 17 on the 17-item Hamilton Rating Scale for Depression (HAM-D17). No minimal MDD duration necessary for study participation
* Failure to respond to a minimum of 2 trials of antidepressant medication
* Failure to respond from at least two different agent classes
* Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count)
* Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration\*
* Must have a confirmed FM or ME/CFS diagnoses and moderate pain complaints, minimum score of 15 on the McGill Pain Questionnaire.
* Pain chronicity for at least 3 months prior to study enrollment.
* Subjects are willing and able to adhere to the treatment schedule and required study visits.
Exclusion Criteria:
* Are mentally or legally incapacitated, unable to give informed consent.
* Are pregnant.
* Have an active suicidal intent or plan.
* Have had prior Transcranial Magnetic Stimulation treatment.
* Have an infection or poor skin condition over the scalp where the device will be positioned.
* Have increased risk of seizure because of f…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Percent change in depression scores
Timeframe: Through study completion, an average of 6 weeks
2
Percent change in pain score
Timeframe: Through study completion, an average of 6 weeks