Neuromodulation for Comorbid Hoarding Disorder and Depression

Not Applicable

Active, not recruiting

• Conditions: Hoarding Disorder; Hoarding; Depression
• Interventions: Device: iTBS

• Registration Number: NCT05985356
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-14
• Study Start: 2023-08-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iTBS	iTBS	intermittent Theta Burst Stimulation (a form of transcranial magnetic stimulation) targeting the left dorsolateral prefrontal cortex

Primary Outcome Measures

Name	Time	Method
Savings Inventory -- Revised	change from baseline to 8 weeks	self-reported symptoms of hoarding disorder
Hamilton Rating Scale for Depression	change from baseline to 8 weeks	depression symptom severity

Secondary Outcome Measures

Name	Time	Method
resting state functional connectivity	change from baseline to 4 weeks	connectivity between subgenual nucleus accumbens and dorsolateral prefrontal cortex as measured by functional magnetic resonance imaging
Patient Health Questionnaire - 9	change from baseline to 8 weeks	self-reported symptoms of depression
Hoarding Rating Scale	change from baseline to 8 weeks	self-reported symptoms of hoarding disorder
Neuropsychological Global Deficit Score	change from baseline to 8 weeks	neurocognition composite

Trial Locations

Locations (1)

UC San Diego; 🇺🇸 La Jolla, California, United States