NCT06524505 Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression
| NCT ID | NCT06524505 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Anding Hospital |
| Condition | Bipolar Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-08-01 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. We hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06524505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bipolar Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06524505 currently recruiting?
Yes, NCT06524505 is actively recruiting participants. Contact the research team at jieli@tjmhc.com for enrollment information.
Where is the NCT06524505 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06524505 clinical trial?
NCT06524505 is sponsored by Tianjin Anding Hospital. The trial plans to enroll 100 participants.
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