Neuromodulation for Hoarding Disorder and Depression

Overseen By Jessica Zakrzewski, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Anticonvulsants, Seizure threshold-lowering

Disqualifiers: Neurological conditions, Implanted devices, Psychotic illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called intermittent theta burst stimulation (iTBS) to determine its effectiveness for individuals with both depression and hoarding disorder. The researchers aim to discover if iTBS can improve not only depression but also hoarding symptoms, cognitive abilities, and brain connectivity. Suitable candidates for this trial have major depression and hoarding disorder, maintain stable medication routines, and can adhere to the study schedule.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

Do I have to stop taking my current medications for the trial?

The trial requires that you stay on your current psychiatric medications if they have been stable for 6 weeks, and no changes are expected during the study period. However, if you are taking lorazepam 2 mg or greater daily (or benzodiazepine equivalent), any anticonvulsant, or medication that lowers seizure threshold, you may not be eligible to participate.

What prior data suggests that iTBS is safe for treating depression and hoarding disorder?

Research has shown that intermittent theta burst stimulation (iTBS) is generally safe and well-tolerated. One study applied iTBS to a part of the brain involved in mood regulation and found it safely improved depression symptoms. Another study with young adults found that both once-daily and twice-daily iTBS treatments were safe and did not cause serious side effects. These findings suggest that people receiving iTBS for depression and hoarding disorder can expect similar safety. Always consult a healthcare professional before joining any trial to understand potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intermittent Theta Burst Stimulation (iTBS) for hoarding disorder and depression because of its novel approach to brain stimulation. Unlike traditional treatments, which often involve medication or cognitive behavioral therapy, iTBS uses transcranial magnetic stimulation to target the left dorsolateral prefrontal cortex, a brain area associated with decision-making and emotional regulation. This non-invasive method could offer quicker results and fewer side effects than medication, making it a promising alternative for those who haven't found relief with standard therapies.

What evidence suggests that iTBS is effective for treating depression and hoarding disorder?

Research shows that intermittent theta burst stimulation (iTBS), which participants in this trial will receive, can effectively reduce depression symptoms. Studies have found that just two days of iTBS, targeting a specific brain area, can quickly and safely improve depression, especially in young people. This treatment is considered safe and generally well-tolerated. For individuals with obsessive-compulsive disorder, iTBS has shown positive results when combined with other treatments. Although less information exists on its effects on hoarding disorder, the success of iTBS in treating depression suggests it might also help with symptoms in those who have both conditions. ^{1 2 3 4 5}

Who Is on the Research Team?

Elizabeth Twamley, PhD

Principal Investigator

UC San Diego

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with both depression and hoarding disorder, who have been stable on psychiatric meds for 6 weeks. They must be able to commit to the treatment schedule, complete assessments in English, and not have any MRI or TMS contraindications. Pregnant individuals or those with certain neurological conditions or high suicide risk are excluded.

Inclusion Criteria

Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms

Stated willingness to comply with all study procedures and availability for the duration of the study

My psychiatric medications have been stable for 6 weeks and won't change during the study.

Exclusion Criteria

Current substance use disorder per DIAMOND

I am on medication that increases my risk of seizures.

Pregnant or intending to become pregnant within the study period; breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iTBS

Trial Overview The study tests intermittent theta burst stimulation (iTBS) effectiveness on treating depression in patients also suffering from chronic hoarding disorder. It will assess improvements in hoarding symptoms, cognitive function, and brain connectivity related to the treatment.

How Is the Trial Designed?

Group I: iTBS Experimental Treatment 1 Intervention

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

iTBS is already approved in United States for the following indications:

Approved in United States as iTBS for:

• Treatment-resistant depression
• Major depressive disorder

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

Accelerated intermittent Theta Burst Stimulation (iTBS) was found to be safe and well tolerated in a study of 50 treatment-resistant depressed patients, with no worsening of suicidal ideation observed during the treatment.

The study showed a significant decrease in suicide risk, as measured by the Beck Scale of Suicide Ideation, lasting up to one month after treatment, regardless of whether patients received active or sham stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial. Desmyter, S., Duprat, R., Baeken, C., et al.[2020]

In a study of 27 participants, a prolonged intermittent theta burst stimulation (piTBS) protocol using 1,800 pulses showed limited effectiveness for major depressive disorder, with only 18.2% of participants achieving a response and 9.1% reaching remission.

Safety and tolerability were concerns, as 18.5% of participants experienced issues, suggesting that while piTBS is a promising approach, further research is needed to optimize its parameters and improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. Richard, M., Noiseux, C., Desbeaumes Jodoin, V., et al.[2022]

In a randomized, double-blind trial involving 56 patients, intermittent theta burst stimulation (iTBS) over the dorsomedial prefrontal cortex showed a significant reduction in negative symptoms for patients with depression, but not for those with schizophrenia.

The treatment was generally safe and well-tolerated, with serious adverse events occurring only in the sham group, indicating that iTBS may be a promising intervention for depressive symptoms in certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsomedial prefrontal theta burst stimulation to treat anhedonia, avolition, and blunted affect in schizophrenia or depression - a randomized controlled trial. Bodén, R., Bengtsson, J., Thörnblom, E., et al.[2021]

Theta-burst stimulation (TBS) shows promise as a rapid and effective treatment for psychiatric disorders, particularly treatment-resistant depression and auditory hallucinations, with studies indicating mild adverse effects but no severe complications like seizures or mania.

The current research on TBS is varied in design and outcomes, highlighting the need for more rigorous sham-controlled studies to better assess its long-term safety and efficacy in treating various psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Theta-Burst Stimulation in the Treatment of Psychiatric Disorders: A Review of the Literature. Rachid, F.[2019]

Continuous theta burst stimulation (cTBS) was found to be safe and well-tolerated in patients with major depressive disorder (MDD) or bipolar depression (BD), with no significant differences in adverse events compared to sham treatment.

However, the meta-analysis of three randomized controlled trials involving 78 participants showed no significant improvement in depression scores or response rates with cTBS compared to sham, indicating that cTBS may not provide a therapeutic advantage for treating major depressive episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive continuous theta burst stimulation for major depressive disorder or bipolar depression: A meta-analysis of randomized controlled studies. Cai, DB., Qin, XD., Qin, ZJ., et al.[2023]

In a study of 26 patients with bipolar depression, active intermittent theta burst stimulation (iTBS) showed a high response rate of 72% and a remission rate of 42%, indicating its potential efficacy in treating this condition.

No adverse events were reported, demonstrating that iTBS is safe and well-tolerated, but further research with larger sample sizes is needed to confirm its superiority over sham treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled Pilot Study. Bulteau, S., Beynel, L., Marendaz, C., et al.[2020]

A clinical trial involving 96 outpatients with moderate depression will investigate the effectiveness of intermittent theta burst stimulation (iTBS) on reducing depressive symptoms, comparing it to a sham treatment over ten sessions.

The study will also explore various factors, including genetic and neuropsychological measures, that may influence the response to iTBS, ensuring a thorough safety screening and adherence to ethical guidelines throughout the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial. Ørbo, MC., Grønli, OK., Larsen, C., et al.[2023]

Accelerated, high-dose intermittent theta burst stimulation (iTBS) showed promising results in treating highly treatment-resistant depression, with most patients achieving remission after treatment.

However, the effects were short-lived, as all patients experienced relapse within two weeks, indicating a need for improved treatment strategies that enhance the durability of the therapeutic response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is accelerated, high-dose theta burst stimulation a panacea for treatment-resistant depression? Caulfield, KA.[2021]

In a study of 22 participants with treatment-resistant depression, the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) protocol, which uses high-dose intermittent theta-burst stimulation (iTBS) guided by functional connectivity MRI, showed a remarkable remission rate of 90.5%.

The treatment was well tolerated with no negative cognitive side effects reported, suggesting that SAINT could be a safe and effective option for patients who have not responded to traditional antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Cole, EJ., Stimpson, KH., Bentzley, BS., et al.[2020]

In a study involving 72 patients with major depressive disorder, two daily sessions of prolonged intermittent theta-burst stimulation (piTBS) over two weeks showed significantly more responders compared to a sham treatment, indicating its efficacy as an antidepressant option.

However, the study found no evidence that longer piTBS sessions led to greater improvements in depression scores compared to other treatments, suggesting that while piTBS is effective, increasing treatment duration does not enhance its antidepressant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The longer, the better ? Longer left-sided prolonged intermittent theta burst stimulation in patients with major depressive disorder: A randomized sham-controlled study. Li, CT., Cheng, CM., Lin, HC., et al.[2023]

In a study of 50 depressed patients undergoing accelerated intermittent theta burst stimulation (aiTBS), baseline cortical thickness in the right caudal part of the anterior cingulate cortex (cACC) was found to significantly correlate with immediate clinical responses to treatment.

Longitudinal changes in cortical thickness in the right cACC also predicted delayed clinical responses, suggesting that this brain region could serve as a biomarker for determining the effectiveness of aiTBS in treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical Thickness in the Right Anterior Cingulate Cortex Relates to Clinical Response to Left Prefrontal Accelerated Intermittent Theta Burst Stimulation: An Exploratory Study. Baeken, C., van Beek, V., Vanderhasselt, MA., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39761754/

Efficacy study of intermittent theta burst stimulation(iTBS) in ... The current study suggests that two days of active iTBS to the DLPFC region can rapidly, safely, and effectively improve depressive symptoms in adolescents ...

2. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.20240181

Intermittent Theta Burst Stimulation With Adjunctive D- ... Intermittent theta burst stimulation with adjunctive d-cycloserine for obsessive-compulsive disorder: a randomized clinical trial.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38199406/

Efficacy and safety of intermittent theta burst stimulation on ... The current results indicated that twice-daily and once-daily iTBS under neuronavigation are safe and well tolerated in AYA-MDD, but the overall efficacy was ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07033780

NCT07033780 | Theta-Burst Stimulation to Treat Depression The goal of this clinical trial is to explore the effects of non-invasive brain stimulation protocols using intermittent theta-burst stimulation (iTBS) on ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1244289/full

Efficacy and safety of intermittent theta burst stimulation ... The objective of this systematic review was to compare the safety and efficacy of iTBS and high-frequency (≥ 5 Hz) rTMS (HF-rTMS) for patients with treatment- ...