Using deep transcranial magnetic stimulation to treat bipolar depression
Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial
This study is testing if deep transcranial magnetic stimulation can help people with bipolar depression feel better when added to their current treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tianjin Anding Hospital Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06524505 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with bipolar depression who have not achieved remission from pharmacological treatments.
Not a fit: Patients with previous rTMS treatment, significant medical or psychiatric comorbidities, or those currently experiencing acute psychosis or suicidality may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide an effective non-pharmacological option for managing bipolar depression and improving cognitive function.
How similar studies have performed: While the use of dTMS is a relatively novel approach, previous studies have shown promising results in treating depression with similar techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tianjin
- Tianjin Anding Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Jie Li, Doctor
- Email: jieli@tjmhc.com
- Phone: +86 022 88188006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.