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Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

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.

ClinicalTrials.gov IDNCT06524505

PhaseNA

Enrollment100

SponsorTianjin Anding Hospital

Age18 Years – 65 Years

SexALL

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Conditions studied

Bipolar Depression

About this study

Interventions

Device: deep Transcranial Magnetic Stimulation (dTMS) -active — with the H1-coil device included 20-min sessions of 18 Hz (2-s trains separated by 20-s inter-train intervals, 55 trains totaling 1980 pulses/session).
Device: deep Transcranial Magnetic Stimulation (dTMS) -sham — The sham stimulation was performed using the same procedures, with the sham coil.

Primary outcomes

The change over time in the score of Hamilton Depression Rating Scale (HDRS-17). (baseline, week 2, week 4, week 8)

Eligibility information

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.

Study locations

Tianjin Anding Hospital, Tianjin, China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-08.