Clinical trial NCT05985356: Neuromodulation for Comorbid Hoarding Disorder and Depression
Official title: Neuromodulation for Comorbid Hoarding Disorder and Depression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hoarding Disorder
Hoarding
Depression
Keywords: TMS
Transcranial magnetic stimulation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male, female, or non-gender conforming individuals (i.e. those who do not identify as male or female)
4. All racial and ethnic groups
5. Ages 18 to 70
6. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per HAM-D and DIAMOND.
7. Meets criteria for current Hoarding Disorder, per SIHD
8. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
9. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period
10. No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)
11. No contraindications to MRI (passes MRI safety screening questionnaire)
12. Able to commit to the treatment schedule
13. Able to complete assessment procedures in English
14. Intact decision-making capacity and ability to provide voluntary informed consent

Exclusion Criteria:

1. 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
2. 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
3. Active manic or psychotic illness per DIAMOND
4. Current substance use disorder per DIAMOND
5. 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.
6. Pregnant or intending to become pregnant within the study period; breastfeeding
7. Other sensory conditions or illnesses precluding participation in assessments or treatment
8. Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy
9. Taking medication that lowers seizure threshold
10. Previous failed treatment with rTMS, iTBS, or ECT

Primary outcomes:
measure: Savings Inventory -- Revised
timeFrame: change from baseline to 8 weeks
measure: Hamilton Rating Scale for Depression
timeFrame: change from baseline to 8 weeks
Secondary outcomes:
measure: Hoarding Rating Scale
timeFrame: change from baseline to 8 weeks
measure: Patient Health Questionnaire - 9
timeFrame: change from baseline to 8 weeks
measure: Neuropsychological Global Deficit Score
timeFrame: change from baseline to 8 weeks
measure: resting state functional connectivity
timeFrame: change from baseline to 4 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
affiliation: UC San Diego
name: Elizabeth Twamley, PhD
role: PRINCIPAL_INVESTIGATOR
References: