ClinicalTrials.gg
CompletedNCT05985356Updated Jun 17, 2026Results posted

Neuromodulation for Comorbid Hoarding Disorder and Depression

An interventional study of iTBS in Hoarding Disorder, Hoarding and Depression, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hoarding Disorder
  • Hoarding
  • Depression

Keywords

  • TMS
  • Transcranial magnetic stimulation
03

In context

Hoarding Disorder

32 studies on the registry are indexed under Hoarding Disorder; 5 are open to participants now.

This study's enrollment of 14 is below the median of 37 across 28 interventional studies indexed under Hoarding Disorder.

Browse Hoarding Disorder studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed and dated 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 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

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; 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    iTBS

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

    Device: iTBS

Interventions

  • DeviceiTBS

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

    Also known as: rTMS

06

What researchers measure

Primary outcomes

  1. Saving Inventory -- Revised

    Saving Inventory - Revised, measuring hoarding symptom severity. Min=0, Max=92. Higher scores indicate more severe hoarding symptoms.

    Time frame: change from baseline to 8 weeks

  2. 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.

    Time frame: change from baseline to 8 weeks

Secondary outcomes

  1. Hoarding Rating Scale

    Hoarding Rating Scale, measuring hoarding symptom severity. Min=0, Max=40. Higher scores represent more severe hoarding symptoms.

    Time frame: change from baseline to 8 weeks

  2. Patient Health Questionnaire - 9

    Patient Health Questionnaire - 9, measuring depression symptom severity. Min=0, Max=27. Higher scores indicate more severe depression symptoms.

    Time frame: change from baseline to 8 weeks

  3. Neuropsychological Global Deficit Score

    Neuropsychological Global Deficit Score, measuring global cognitive performance. Min=0, Max=5. Higher scores indicate worse cognitive performance.

    Time frame: change from baseline to 8 weeks

  4. 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.

    Time frame: change from baseline to 4 weeks

07

Results

Posted Jun 17, 2026

Participant flow

Participants were initially recruited from a waitlist for HD treatment in the San Diego, California area. However, participants also found the study online via clinicaltrials.gov

Participant flow — Overall Study
MilestoneiTBS
Started11
Completed10
Not completed1
Withdrew: Withdrawal by subject1

Outcome measures

PrimarySaving Inventory -- Revised

Saving Inventory - Revised, measuring hoarding symptom severity. Min=0, Max=92. Higher scores indicate more severe hoarding symptoms.

Time frame:
change from baseline to 8 weeks
Reported as:
Mean · score on a scale
Saving Inventory -- Revised
score on a scaleiTBS
Saving Inventory -- Revised50.6 ± 16.6
PrimaryHamilton Rating Scale for Depression

Hamilton Rating Scale for Depression, measuring depression symptom severity. Min=0, Max=50. Higher scores represent more severe depression symptoms.

Time frame:
change from baseline to 8 weeks
Reported as:
Mean · score on a scale
Hamilton Rating Scale for Depression
score on a scaleiTBS
Hamilton Rating Scale for Depression11.0 ± 7.2
SecondaryHoarding Rating Scale

Hoarding Rating Scale, measuring hoarding symptom severity. Min=0, Max=40. Higher scores represent more severe hoarding symptoms.

Time frame:
change from baseline to 8 weeks
Reported as:
Mean · score on a scale
Hoarding Rating Scale
score on a scaleiTBS
Hoarding Rating Scale11.0 ± 7.2
SecondaryPatient Health Questionnaire - 9

Patient Health Questionnaire - 9, measuring depression symptom severity. Min=0, Max=27. Higher scores indicate more severe depression symptoms.

Time frame:
change from baseline to 8 weeks
Reported as:
Mean · score on a scale
Patient Health Questionnaire - 9
score on a scaleiTBS
Patient Health Questionnaire - 910.4 ± 8.5
SecondaryNeuropsychological Global Deficit Score

Neuropsychological Global Deficit Score, measuring global cognitive performance. Min=0, Max=5. Higher scores indicate worse cognitive performance.

Time frame:
change from baseline to 8 weeks
Reported as:
Mean · Points on a scale
Neuropsychological Global Deficit Score
Points on a scaleiTBS
Neuropsychological Global Deficit Score.03 ± .06
SecondaryResting 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.

Time frame:
change from baseline to 4 weeks
Reported as:
Mean · Fisher's Z score
Resting State Functional Connectivity
Fisher's Z scoreiTBS
Resting State Functional Connectivity-.089 ± .069

Adverse events

Collected over from enrollment until end of follow-up, up to 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
iTBS0/11 (0%)0/11 (0%)0/11 (0%)

Baseline characteristics

3 participants not assigned to treatment due to not completing baseline assessment (1) or not meeting study criteria (2)

Age, Continuous
Age, Continuous(years)iTBS
Mean52 (27 to 68)
Sex: Female, Male
Sex: Female, Male(Participants)iTBS
Female6
Male5
Race (NIH/OMB)
Race (NIH/OMB)(Participants)iTBS
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American0
White10
More than one race0
Unknown or Not Reported0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)iTBS
Hispanic or Latino2
Not Hispanic or Latino9
Unknown or Not Reported0
HAM-D
HAM-D(score on a scale)iTBS
Mean22.4 ± 3.2
PHQ-9
PHQ-9(score on a scale)iTBS
Mean16.6 ± 5.0
HRS
HRS(score on a scale)iTBS
Mean30.6 ± 5.3
SI-R
SI-R(score on a scale)iTBS
Mean63.7 ± 9.2

2 further baseline measures are reported on the registry.

08

Study locations

1 site
  • UC San Diego
    La Jolla, California 92093, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Data can be de-identified and made available upon request.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05985356
Responsible party
Elizabeth Twamley (Professor of Psychiatry, University of California, San Diego) — Principal investigator
First posted
Aug 14, 2023
Start date
Aug 28, 2023
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025
Results posted
Jun 17, 2026
Last update
Jun 17, 2026

Study contacts

Elizabeth Twamley, PhD
principal investigator · UC San Diego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion