Neuromodulation for Comorbid Hoarding Disorder and Depression

NCT05985356 | Completed FDA Device

• 1 other identifier: RG106837
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Hoarding Disorder; Hoarding; Depression

Keywords

TMS; Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Savings Inventory -- Revised

  self-reported symptoms of hoarding disorder

  change from baseline to 8 weeks

• Hamilton Rating Scale for Depression

  depression symptom severity

  change from baseline to 8 weeks

Secondary Outcomes (4)

• Hoarding Rating Scale

  change from baseline to 8 weeks

• Patient Health Questionnaire - 9

  change from baseline to 8 weeks

• Neuropsychological Global Deficit Score

  change from baseline to 8 weeks

• resting state functional connectivity

  change from baseline to 4 weeks

Study Arms (1)

iTBS

EXPERIMENTAL

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

Device: iTBS

Interventions

iTBS DEVICE

iTBS targeting the left dorsolateral prefrontal cortex; 20 sessions over 4 weeks.

Also known as: rTMS

iTBS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
• Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period
• No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)
• No contraindications to MRI (passes MRI safety screening questionnaire)
• Able to commit to the treatment schedule
• Able to complete assessment procedures in English
• Intact decision-making capacity and ability to provide voluntary informed consent

You may not qualify if:

• 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
• Taking medication that lowers seizure threshold
• Previous failed treatment with rTMS, iTBS, or ECT

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Hoarding Disorder; Hoarding; Depression

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Behavior; Behavioral Symptoms

Study Officials

• Elizabeth Twamley, PhD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: August 28, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)