Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
⁃ 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.
Locations
Other Locations
China
Tianjin Anding Hospital
RECRUITING
Tianjin
Contact Information
Primary
Jie Li, Doctor
jieli@tjmhc.com
+86 022 88188006
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-02
Participants
Target number of participants: 100
Treatments
Experimental: dTMS group
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).
Sham_comparator: sham group
The sham stimulation was performed using the same procedures, with the sham coil.
Related Therapeutic Areas
Sponsors
Leads: Tianjin Anding Hospital