Neuromodulation for Comorbid Hoarding Disorder and Depression

Depression Clinical Trial

Official title:

Neuromodulation for Comorbid Hoarding Disorder and Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985356
• Other study ID #: RG106837
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: University of California, San Diego
• Contact: Jessica Zakrzewski, PhD
• Phone: 858-255-1257
• Email: jzakrzewski[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Hoarding
• Hoarding Disorder

Intervention

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

Locations

Country	Name	City	State
United States	UC San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Savings Inventory -- Revised	self-reported symptoms of hoarding disorder	change from baseline to 8 weeks
Primary	Hamilton Rating Scale for Depression	depression symptom severity	change from baseline to 8 weeks
Secondary	Hoarding Rating Scale	self-reported symptoms of hoarding disorder	change from baseline to 8 weeks
Secondary	Patient Health Questionnaire - 9	self-reported symptoms of depression	change from baseline to 8 weeks
Secondary	Neuropsychological Global Deficit Score	neurocognition composite	change from baseline to 8 weeks
Secondary	resting state functional connectivity	connectivity between subgenual nucleus accumbens and dorsolateral prefrontal cortex as measured by functional magnetic resonance imaging	change from baseline to 4 weeks