Using intermittent theta-burst stimulation to treat major depression

Intermittent Theta-burst Stimulation for Major Depression: an Intensity-response Study

This study is testing if a gentler form of brain stimulation can help people with major depression feel better, especially those who haven't found relief with regular medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 246 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Hong Kong Polytechnic University (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06392867 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of intermittent theta-burst stimulation (iTBS) as a treatment for major depressive disorder (MDD). iTBS is a form of repetitive transcranial magnetic stimulation (rTMS) that has been FDA-approved and is known for its safety and efficiency, particularly for patients who do not respond to standard antidepressant treatments. The study aims to determine the optimal stimulation intensity for iTBS, as current practices use a standard intensity of 120% of the resting motor threshold, which may cause discomfort. By exploring lower intensities, the research seeks to improve patient adherence and treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with a diagnosis of major depressive disorder who have not responded to multiple standard antidepressant treatments.

Not a fit: Patients with active suicidal intent, unstable medical conditions, or recent substance abuse may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more tolerable and effective treatment option for patients suffering from major depression.

How similar studies have performed: Other studies have shown promising results with similar approaches using transcranial magnetic stimulation, but this specific intensity-response investigation is relatively novel.

Eligibility criteria

Inclusion Criteria:

* are aged between 18 and 70;
* have a MDD diagnosis, single or recurrent episode, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria and confirmed by means of the Mini-International Neuropsychiatric Interview (MINI);
* have a score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HDRS17) in their current episode;
* have failed to have a clinically significant response to two or more standard antidepressant treatments during their current episode;
* have received stable psychopharmacological treatment within 4 weeks prior to screening; and
* have normal thyroid function, Complete Blood Count, electrolytes, and liver enzyme levels based on pre-study blood work.

Exclusion Criteria:

* have a history of substance abuse or dependence in the past 3 months;
* have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump;
* show active suicidal intent (MADRS item 10 score \>4);
* are pregnant;
* have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms;
* have a metal implant or any other common MRI and TMS exclusion criteria;
* take antiepileptic drugs or benzodiazepines corresponding to a dose of \>1 mg lorazepam per day;
* have had initiation or dose change of any psychotropic medication in the 4 weeks prior to screening or
* have undergone TMS in the past.

Where this trial is running

Hong Kong

• The Hong Kong Polytechnic University — Hong Kong, Hong Kong (Recruiting)

Study contacts

• Principal investigator: Georg Kranz, PhD — The Hong Kong Polytechnic University
• Study coordinator: Georg Kranz, PhD

Conditions Depression, Unipolar; Transcranial magnetic stimulation, TMS; Major Depressive Disorder; iTBS; TMS treatment for depression