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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTianjin Anding Hospital

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • deep Transcranial Magnetic Stimulation (dTMS) -active
  • deep Transcranial Magnetic Stimulation (dTMS) -sham

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators