Depression, Hoarding, Hoarding Disorder
Conditions
Keywords
TMS, Transcranial magnetic stimulation
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.
Interventions
DEVICEiTBS
iTBS targeting the left dorsolateral prefrontal cortex; 20 sessions over 4 weeks.
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Saving Inventory -- Revised | change from baseline to 8 weeks | Saving Inventory - Revised, measuring hoarding symptom severity. Min=0, Max=92. Higher scores indicate more severe hoarding symptoms. |
| Hamilton Rating Scale for Depression | 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
| Measure | Time frame | Description |
|---|---|---|
| Hoarding Rating Scale | change from baseline to 8 weeks | Hoarding Rating Scale, measuring hoarding symptom severity. Min=0, Max=40. Higher scores represent more severe hoarding symptoms. |
| Patient Health Questionnaire - 9 | 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. |
| Neuropsychological Global Deficit Score | change from baseline to 8 weeks | Neuropsychological Global Deficit Score, measuring global cognitive performance. Min=0, Max=5. Higher scores indicate worse cognitive performance. |
| Resting State Functional Connectivity | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth Twamley, PhD
UC San Diego
Participant flow
Recruitment details
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
Pre-assignment details
This was a single group study. Participants completed baseline assessment and then began treatment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HAM-D | 22.4 score on a scale STANDARD_DEVIATION 3.2 |
| HRS | 30.6 score on a scale STANDARD_DEVIATION 5.3 |
| Neuropsychological Global Deficit Score | .18 Points on a scale STANDARD_DEVIATION 0.26 |
| PHQ-9 | 16.6 score on a scale STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Resting state functional connectivity | -.095 Fisher's Z-score STANDARD_DEVIATION 0.057 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 5 Participants |
| SI-R | 63.7 score on a scale STANDARD_DEVIATION 9.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
None listed