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RECRUITINGINTERVENTIONAL

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

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 waiting period after previous treatment followed by re-evaluation. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (1)

Tianjin Anding Hospital
Tianjin, China