Hoarding DisorderNCT05985356
Neuromodulation for Comorbid Hoarding Disorder and Depression
A study testing iTBS in people with Hoarding Disorder and Hoarding, run by University of California, San Diego at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hoarding Disorder, Hoarding, Depression
- What is being tested?
- iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- iTBS
- Keywords
- TMS, Transcranial magnetic stimulation
- Medical subject headings
- Hoarding Disorder, Hoarding, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBSDevice
Also called rTMS
iTBS targeting the left dorsolateral prefrontal cortex; 20 sessions over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| iTBS | Experimental | intermittent Theta Burst Stimulation (a form of transcranial magnetic stimulation) targeting the left dorsolateral prefrontal cortex Receives: Device: iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saving Inventory -- Revised
Saving Inventory - Revised, measuring hoarding symptom severity. Min=0, Max=92. Higher scores indicate more severe hoarding symptoms.
Measured: change from baseline to 8 weeks
Hamilton Rating Scale for Depression
Hamilton Rating Scale for Depression, measuring depression symptom severity. Min=0, Max=50. Higher scores represent more severe depression symptoms.
Measured: change from baseline to 8 weeks
Secondary outcomes (4)
Hoarding Rating Scale
Hoarding Rating Scale, measuring hoarding symptom severity. Min=0, Max=40. Higher scores represent more severe hoarding symptoms.
Measured: change from baseline to 8 weeks
Patient Health Questionnaire - 9
Patient Health Questionnaire - 9, measuring depression symptom severity. Min=0, Max=27. Higher scores indicate more severe depression symptoms.
Measured: change from baseline to 8 weeks
Neuropsychological Global Deficit Score
Neuropsychological Global Deficit Score, measuring global cognitive performance. Min=0, Max=5. Higher scores indicate worse cognitive performance.
Measured: change from baseline to 8 weeks
Resting State Functional Connectivity
Resting state functional connectivity between subgenual cingulate and dorsolateral prefrontal cortex. There are no mathematical minimums or maximums for this Fisher's Z score. Higher values represent greater connection between brain regions.
Measured: change from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start28 Aug 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hoarding DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Twamley, University of California, San Diego
- Investigators
- Elizabeth Twamley, PhD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985356
- Sponsor's protocol ID
- RG106837
- Status last verified
- May 2026
- First submitted
- 2 Aug 2023
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data can be de-identified and made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation for Comorbid Hoarding Disorder and Depression
- ClinicalTrials.gov ID
- NCT05985356
- Acronym / sponsor ID
- RG106837
- Conditions
- Hoarding Disorder, Hoarding, Depression
- Keywords
- TMS, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Posted 17 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iTBS | Experimental | Device: iTBSintermittent Theta Burst Stimulation (a form of transcranial magnetic stimulation) targeting the left dorsolateral prefrontal cortex |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iTBSAlso: rTMSiTBS targeting the left dorsolateral prefrontal cortex; 20 sessions over 4 weeks. | Device | iTBS |
Primary outcome
Saving Inventory -- Revised
Time frame: change from baseline to 8 weeks
Saving Inventory - Revised, measuring hoarding symptom severity. Min=0, Max=92. Higher scores indicate more severe hoarding symptoms.
Hamilton Rating Scale for Depression
Time frame: change from baseline to 8 weeks
Hamilton Rating Scale for Depression, measuring depression symptom severity. Min=0, Max=50. Higher scores represent more severe depression symptoms.
4 secondary outcomes
Hoarding Rating Scale
Time frame: change from baseline to 8 weeks
Patient Health Questionnaire - 9
Time frame: change from baseline to 8 weeks
Neuropsychological Global Deficit Score
Time frame: change from baseline to 8 weeks
Resting State Functional Connectivity
Time frame: change from baseline to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data can be de-identified and made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Twamley, PhD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS in people with Hoarding Disorder and Hoarding, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saving Inventory -- Revised (time frame: change from baseline to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.