Neuromodulation for Comorbid Hoarding Disorder and Depression

NCT ID: NCT05985356

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-28
• Study Completion Date: 2025-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iTBS

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

Group Type: EXPERIMENTAL

iTBS

Intervention Type: DEVICE

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

Interventions

iTBS

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

Intervention Type: DEVICE

Other Intervention Names

rTMS

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Twamley

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Twamley, PhD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Locations

UC San Diego

La Jolla, California, United States

Countries

United States

Other Identifiers

RG106837

Identifier Type: -

Identifier Source: org_study_id