Neuromodulation for Comorbid Hoarding Disorder and Depression (NCT05985356) | Clinical Trial Compass
CompletedNot Applicable
Neuromodulation for Comorbid Hoarding Disorder and Depression
United States14 participantsStarted 2023-08-28
Plain-language summary
The primary goal of this study is to evaluate whether intermittent theta burst stimulation (iTBS) is effective for treating depression in people who have depression and chronic hoarding disorder (HD). The study will also evaluate whether this treatment can improve HD symptoms, cognitive performance, and brain region connectivity. The study team will investigate how the treatment works for depression, as well as other factors that can enhance or hinder treatment, such as pre-treatment level of depression, cognitive performance, or brain region connectivity.
Who can participate
Age range
18 Years – 70 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
. Signed and dated informed consent form
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Male, female, or non-gender conforming individuals (i.e. those who do not identify as male or female)
. All racial and ethnic groups
. Ages 18 to 70
. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per HAM-D and DIAMOND.
. Meets criteria for current Hoarding Disorder, per SIHD
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 used neuromodulation to treat both hoarding disorder and depression at the same time — can you explain what type of neuromodulation was used and whether it might be relevant to my situation?
2Since this trial has already completed, has any data or results been published yet that you could review with me to understand whether it showed meaningful changes on the hoarding and depression rating scales they were measuring?
3The trial tracked outcomes using the Saving Inventory-Revised and the Hamilton Rating Scale for Depression — based on where I score on those kinds of measures, would I have even met the profile of someone included in this study?
4Before considering a neuromodulation approach like the one studied here, are there standard treatments for hoarding disorder or depression that I should try first, and how would we know if those weren't working well enough?
5Because this trial is listed as Phase NA, what does that tell you about how much is still unknown regarding the safety and long-term effectiveness of neuromodulation for hoarding disorder specifically?
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.
. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
Exclusion criteria
. History of other neurological condition including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy
. Implanted medical devices that are not explicitly recognized as MRI safe, including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed
. Active manic or psychotic illness per DIAMOND
. Current substance use disorder per DIAMOND
. Current active suicidal or spontaneously disclosed homicidal ideation. Active suicidal ideation for this study is defined as a score of 3 or greater on the HAMD-17 and/or 3 or more on the PHQ-9.
. Pregnant or intending to become pregnant within the study period; breastfeeding
. Other sensory conditions or illnesses precluding participation in assessments or treatment
. Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy