Using deep transcranial magnetic stimulation to treat bipolar 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 evaluates the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for patients with bipolar depression. It is a randomized, double-blind, sham-controlled trial involving 100 participants who will be assigned to either the dTMS group or a sham-control group. Participants will undergo daily dTMS sessions over four weeks, with assessments of depressive symptoms and cognitive function conducted at baseline, week 2, week 4, and week 8. Blood samples will also be collected at specified intervals to monitor any physiological changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Confirmed diagnosis of bipolar depression;

* age between 18 and 65 years;
* a 17-item Hamilton Depression Rating Scale (HDRS-17) score \>= 17,
* a stable pharmacological regimen maintained for at least 4 weeks prior to the beginning of the treatment phase ;
* for participants who had previously received antidepressant therapy, a minimum 4-week washout period followed by re-evaluation.

Exclusion Criteria:

* a lifetime history of other psychiatric disorders, neurological diseases, or severe brain injury;
* receipt of electroconvulsive therapy, rTMS, transcranial direct current stimulation, transcranial alternating current stimulation, or other neurostimulation treatments within the previous 3 months;
* contraindications to magnetic stimulation, including epilepsy, cardiovascular disorders, or metallic implants in the head;
* the presence of hypomanic/manic symptoms at baseline or a score greater than 12 on the Young Mania Rating Scale (YMRS);
* pregnancy or lactation.

Where it's running

• Tianjin Anding Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Jie Li, Doctor
• Email: jieli@tjmhc.com
• Phone: +86 022 88188006

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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.