Status:
RECRUITING
Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression
Lead Sponsor:
Tianjin Anding Hospital
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
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 effe...
Detailed Description
This is a randomized, double-blind, sham-controlled study to detect the effect of dTMS for treatment of bipolar depression. 100 participants were randomly assigned 1:1 to dTMS group or sham-control gr...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of bipolar depression;
- Met standardized criteria for failure to achieve remission from pharmacological treatment in the current illness episode;
- Pharmacological treatment maintained unchanged for the four weeks preceding rTMS application；
- Able to read, verbalize understanding and voluntarily sign the informed consent form prior to performance of any study-specific procedures or assessments
Exclusion
- Previous treatment with rTMS;
- Ferromagnetic material close to the head;
- Cardiac pacemaker and/or implanted electronic device;
- The presence of neurological disorders (uncontrolled epilepsy, previous significant head injuries, brain surgery);
- Pregnancy or lactation;
- Significant medical and/or psychiatric comorbidities;
- Substance abuse in the last three months (not including caffeine or nicotine);
- Acute psychosis;
- Acute suicidality;
- Patient refuses to sign consent for participation in the study
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06524505
Start Date
November 1 2021
End Date
November 30 2024
Last Update
July 29 2024
Active Locations (1)
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1
Tianjin Anding Hospital
Tianjin, China