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OpenTrials
Completed

NCT Number: NCT05985356

Neuromodulation for Comorbid Hoarding Disorder and Depression

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

iTBS

Device

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

Other names: rTMS

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Hoarding Rating Scale

    Time frame: change from baseline to 8 weeks

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

  2. Patient Health Questionnaire - 9

    Time frame: change from baseline to 8 weeks

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

  3. Neuropsychological Global Deficit Score

    Time frame: change from baseline to 8 weeks

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

  4. Resting State Functional Connectivity

    Time frame: change from baseline to 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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