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Neuromodulation for Comorbid Hoarding Disorder and Depression

Primary Purpose

Hoarding Disorder, Hoarding, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iTBS
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hoarding Disorder focused on measuring TMS, Transcranial magnetic stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC San DiegoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iTBS

Arm Description

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

Outcomes

Primary Outcome Measures

Savings Inventory -- Revised
self-reported symptoms of hoarding disorder
Hamilton Rating Scale for Depression
depression symptom severity

Secondary Outcome Measures

Hoarding Rating Scale
self-reported symptoms of hoarding disorder
Patient Health Questionnaire - 9
self-reported symptoms of depression
Neuropsychological Global Deficit Score
neurocognition composite
resting state functional connectivity
connectivity between subgenual nucleus accumbens and dorsolateral prefrontal cortex as measured by functional magnetic resonance imaging

Full Information

First Posted
August 2, 2023
Last Updated
September 13, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05985356
Brief Title
Neuromodulation for Comorbid Hoarding Disorder and Depression
Official Title
Neuromodulation for Comorbid Hoarding Disorder and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hoarding Disorder, Hoarding, Depression
Keywords
TMS, Transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iTBS
Arm Type
Experimental
Arm Description
intermittent Theta Burst Stimulation (a form of transcranial magnetic stimulation) targeting the left dorsolateral prefrontal cortex
Intervention Type
Device
Intervention Name(s)
iTBS
Other Intervention Name(s)
rTMS
Intervention Description
iTBS targeting the left dorsolateral prefrontal cortex; 20 sessions over 4 weeks.
Primary Outcome Measure Information:
Title
Savings Inventory -- Revised
Description
self-reported symptoms of hoarding disorder
Time Frame
change from baseline to 8 weeks
Title
Hamilton Rating Scale for Depression
Description
depression symptom severity
Time Frame
change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Hoarding Rating Scale
Description
self-reported symptoms of hoarding disorder
Time Frame
change from baseline to 8 weeks
Title
Patient Health Questionnaire - 9
Description
self-reported symptoms of depression
Time Frame
change from baseline to 8 weeks
Title
Neuropsychological Global Deficit Score
Description
neurocognition composite
Time Frame
change from baseline to 8 weeks
Title
resting state functional connectivity
Description
connectivity between subgenual nucleus accumbens and dorsolateral prefrontal cortex as measured by functional magnetic resonance imaging
Time Frame
change from baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Zakrzewski, PhD
Phone
858-255-1257
Email
jzakrzewski@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Twamley, PhD
Organizational Affiliation
UC San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Zakrzewski, PhD
First Name & Middle Initial & Last Name & Degree
Elizabeth Twamley, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data can be de-identified and made available upon request.

Learn more about this trial

Neuromodulation for Comorbid Hoarding Disorder and Depression

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