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Early effects of rTMS on bipolar depression by the modulation of prefrontal-amygdala/striatal brain network

A randomized double-blind controlled study of repetitive transcranial magnetic stimulation in the treatment of bipolar depression

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054169
Enrollment
Unknown
Registered
2021-12-10
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar depression

Interventions

Experimental group:Combination therapy with rTMS and quetiapine
Control group:Combination therapy with sham stimulation and quetiapine

Sponsors

Shenzhen Kangning Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. 18-60 years old, Han nationality, right hand, male or female; 2. Diagnosed with bipolar I depression based on DSM-5; 3. Current depressive episode, HDRS-17 >= 17 and YMRS <= 4; 4. Drug-free (lithium, anticonvulsant, antipsychotic, antidepressant) before enrolled the study; 5. Understanding the study content and signing the informed consent; 6. Junior high school or above, and enough to understand the contents of neuropsychological tests.

Exclusion criteria

Exclusion criteria: 1. Main diagnosis is physical illnesses, physical illness-induced bipolar depression, or other mental disorders; 2. Any mood episode less than 4 times within 12 months; 3. Depression with mixed features; 4. With serious suicidal tendency, suicide item in HDRS-17 >= 3; 5. With severe physical diseases, previous craniocerebral trauma or surgery, previous history of epilepsy, and history of febrile convulsion in childhood; 6. With a history of severe drug allergy; 7. Alcohol or other psychoactive substance abuse; 8. Cannot accept rTMS or neuroimaging scan due to metal implants in the body or other medical conditions; 9. Pregnant or lactating women, plan to conceive, or contraceptive failure.

Design outcomes

Primary

MeasureTime frame
Montgomery-Asberg Depression Rating Scale;Neuroimaging scan;

Secondary

MeasureTime frame
Hamilton Depression Rating Scale, 17-items;Hamilton Anxiety Rating Scale;Young Mania Rating Scale;Clinical Global Impression;Pittsburgh sleep quality indexPittsburgh sleep quality index;MATRICS Consensus Cognitive Battery;

Countries

China

Contacts

Public ContactBai Yuanhan

Shenzhen Kangning Hospital

baiyuanhan@163.com+86 13530242339

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026