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Neuromodulation for Comorbid Hoarding Disorder and Depression

Sponsor
University of California, San Diego (Other)
Overall Status
Recruiting
CT.gov ID
NCT05985356
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
11
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: iTBS
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Neuromodulation for Comorbid Hoarding Disorder and Depression
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: iTBS

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

Device: iTBS
iTBS targeting the left dorsolateral prefrontal cortex; 20 sessions over 4 weeks.
Other Names:
  • rTMS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Savings Inventory -- Revised [change from baseline to 8 weeks]

      self-reported symptoms of hoarding disorder

    2. Hamilton Rating Scale for Depression [change from baseline to 8 weeks]

      depression symptom severity

    Secondary Outcome Measures

    1. Hoarding Rating Scale [change from baseline to 8 weeks]

      self-reported symptoms of hoarding disorder

    2. Patient Health Questionnaire - 9 [change from baseline to 8 weeks]

      self-reported symptoms of depression

    3. Neuropsychological Global Deficit Score [change from baseline to 8 weeks]

      neurocognition composite

    4. resting state functional connectivity [change from baseline to 4 weeks]

      connectivity between subgenual nucleus accumbens and dorsolateral prefrontal cortex as measured by functional magnetic resonance imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC San Diego La Jolla California United States 92093

    Sponsors and Collaborators

    • University of California, San Diego

    Investigators

    • Principal Investigator: Elizabeth Twamley, PhD, UC San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elizabeth Twamley, Professor of Psychiatry, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT05985356
    Other Study ID Numbers:
    • RG106837
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Elizabeth Twamley, Professor of Psychiatry, University of California, San Diego
    TMS
    Transcranial magnetic stimulation
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Hoarding Disorder

    Study Results

    No Results Posted as of Aug 14, 2023