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 range18 Years ā 70 Years
SexALL
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
ā. Signed and dated informed consent form
ā. Stated willingness to comply with all study procedures and availability for the duration of the study
ā. Male, female, or non-gender conforming individuals (i.e. those who do not identify as male or female)
ā. All racial and ethnic groups
ā. Ages 18 to 70
ā. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per HAM-D and DIAMOND.
ā. Meets criteria for current Hoarding Disorder, per SIHD
ā. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
Exclusion criteria
ā. 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
ā. 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
ā. Active manic or psychotic illness per DIAMOND
ā. Current substance use disorder per DIAMOND
ā. 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.
ā. Pregnant or intending to become pregnant within the study period; breastfeeding
ā. Other sensory conditions or illnesses precluding participation in assessments or treatment
ā. Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy