Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression
Recruiting · NCT06524505 · Interventional (participants receive a specific treatment) · Lead sponsor: Tianjin Anding Hospital
View the official record on ClinicalTrials.gov →Interventions studied
deep Transcranial Magnetic Stimulation (dTMS) -activedeep Transcranial Magnetic Stimulation (dTMS) -sham
What this trial is about
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 can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Tianjin Anding Hospital - Tianjin, China