NCT04998097

The Role of iTBS in Bipolar II Depression

Status unknown NA Last updated 4 October 2023

What this trial tests

NA trial testing repetitive transcranial magnetic stimulation (rTMS) in Bipolar II Disorder, Most Recent Episode Major Depressive in 60 participants. Status unknown.

Timeline

23 May 2022

Primary endpoint
31 March 2024

31 March 2024

Quick facts

Lead sponsor	Kaohsiung Veterans General Hospital.
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	23 May 2022
Primary completion	31 March 2024
Estimated completion	31 March 2024
Sites	1 location across Taiwan

Drugs / interventions tested

• repetitive transcranial magnetic stimulation (rTMS)
• sham repetitive transcranial magnetic stimulation (rTMS)

Conditions studied

• Bipolar II Disorder, Most Recent Episode Major Depressive — all drugs for Bipolar II Disorder, Most Recent Episode Major Depressive →

Sponsor

Kaohsiung Veterans General Hospital.

Who can join

Adults 20 to 65, any sex, with Bipolar II Disorder, Most Recent Episode Major Depressive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is a paucity of evidence-supported treatment choices for bipolar II depression (BD-II depression), hindered by multiple comorbidity and manic switch. In addition, a slower response also burdens the patients. Intermittent theta-burst stimulation (iTBS) is a new form of Repetitive transcranial magnetic stimulation (rTMS) which is more powerful and requires less time of operation (i.e., about 1/3 of traditional treatment time) compared to traditional rTMS protocols. The antidepressant effect of iTBS for major depressive disorder is well established; however, its effect for BD-II depression is still undetermined with few investigations. In the current study, the investigators plan to conduct a randomized, controlled study to directly compare antidepressant effects of iTBS (n=30) versus sham (n=30) for BD-II depression under treatment of quetiapine monotherapy. The participants will receive 10 times of iTBS sessions in 2 weeks (daily from Monday to Friday and off on the weekends for 2 weeks), followed on the end of week 2 (right after treatment,), week 6 and week 12. The investigators hypothesize that iTBS is effective for BD-II depression and may improve cognitive decline associated with BD-II. In addition, the investigators have identified several microRNAs (miRNAs) (miR-7-5p, miR-142-3p, miR-221-5p, and miR-370-3p) which may aid the diagnosis of BD-II and such diagnostic model was patented in Taiwan. The investigators further found significant correlations with these miRNAs with peripheral levels of brain derived neurotrophic factor (BDNF). The investigators inferred that these miRNAs may be associated with susceptibility with BD-II thru modulation of BDNF. Because modulation of BDNF level is one of the anti-depression mechanism for rTMS, the investigators plan to monitor the changes of these candidate miRNAs and BDNF levels in serum before and after iTBS treatment (week 0, 2,6,12), in attempt to clarify whether these miRNAs may be treatment biomarker as well. The investigators believe that the current study result may be a great addition for predictor for therapeutic assessment and precision treatment of BD-II depression.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.