Using intermittent theta-burst stimulation to treat major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: georg.kranz@polyu.edu.hk
• Phone: 27664838

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.