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

NCT06524505 | Recruiting DMC

• 1 other identifier: dTMS-TJAH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• The change over time in the score of Hamilton Depression Rating Scale (HDRS-17).

  The aim is to explore whether deep Transcranial Magnetic Stimulation (dTMS) combined with Pharmacological treatment could alleviate the severity of depressive symptoms as measured with HDRS-17 in bipolar depression after 4-week treatment. Hamilton Depression Rating Scale (HDRS-17) was used to evaluate the severity of symptoms of depression. Higher total score of the scale means more severe depressive symptoms.

  baseline, week 2, week 4, week 8

Secondary Outcomes (5)

• Response and remission rates at weeks 2, week 4 and week 8 with HDRS-17.

  weeks 2, week 4 and week 8

• The change of scores in MATRICS Consensus Cognitive Battery(MCCB)

  baseline, week 4, week 8

• The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)

  baseline, week 2, week 4, week 8

• The changes of levels of Brain Derived Neurotrophic Factor (BDNF) in peripheral blood

  baseline, week 4, week 8

• The change of scores of adverse events scale from baseline to week 4

  baseline, week 4

Study Arms (2)

dTMS group

EXPERIMENTAL

Participants receive active stimulation with H1 coil, consisting of 55 18 Hz, 2 s trains at 120% MT intensity, with a between-train interval of 20 s ,1980 pulses per day. The subjects were stimulated every day for 4 weeks (except weekends).

Device: deep Transcranial Magnetic Stimulation (dTMS) -active

sham group

SHAM COMPARATOR

The sham stimulation was performed using the same procedures, with the sham coil.

Device: deep Transcranial Magnetic Stimulation (dTMS) -sham

Interventions

deep Transcranial Magnetic Stimulation (dTMS) -active DEVICE

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).

dTMS group

deep Transcranial Magnetic Stimulation (dTMS) -sham DEVICE

The sham stimulation was performed using the same procedures, with the sham coil.

sham group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

Tianjin Anding Hospital

Tianjin, China

RECRUITING

Related Publications (1)

• Chu L, Jia X, Gao P, Sun X, Zhang J, Ding Y, Chen S, Bi F, Zhang C, Li D, Zhang Y. Effects of Deep Transcranial Magnetic Stimulation on Cognitive Function in Bipolar Depression: A Randomized Controlled Trial Using the MATRICS Consensus Cognitive Battery. Alpha Psychiatry. 2026 Feb 28;27(1):47409. doi: 10.31083/AP47409. eCollection 2026 Feb.

  PMID: 41788133 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Jie Li, Doctor

CONTACT

+86 022 88188006; jieli@tjmhc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)