The Role of iTBS in Bipolar II Depression

NCT04998097 | Unknown

• 1 other identifier: 21-CT3-23(210303-1)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar II Disorder, Most Recent Episode Major Depressive

Keywords

rTMS; BDNF; micro RNA; cognitive function

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS)

  Clinical depression severity will be assessed by the HDRS. The total score range is from 0 to 52. Higher scores (\>=18) indicate a greater degree of depression. A significant change in the score is considered a response to rTMS. HDRS will be assessed from baseline, week2, week 6,and week12.

  Baseline, week 2 (after rTMS intervention), week6, week 12 (endpoint).

Secondary Outcomes (1)

• Young Mania Rating Scale (YMRS)

  Baseline, week 2 (after rTMS intervention), week6, week 12 (endpoint).

Other Outcomes (3)

• Brief Assessment of Cognition in Affective Disorders (BACA)

  Baseline, endpoint (week 12)

• plasma miRNA

  Baseline, week 2 (after rTMS intervention), week6, week 12 (endpoint).

• plasma BDNF level

  Baseline, week 2 (after rTMS intervention), week6, week 12 (endpoint).

Study Arms (2)

experimental (iTBS group)

EXPERIMENTAL

device: Magstim Rapid2 Stimulator

Device: repetitive transcranial magnetic stimulation (rTMS)

sham group

SHAM COMPARATOR

device shame Magstim Rapid2 Stimulator

Device: sham repetitive transcranial magnetic stimulation (rTMS)

Interventions

repetitive transcranial magnetic stimulation (rTMS) DEVICE

Investigators adopted the iTBS protocol which follows the standard TBS protocols, with 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 80% motor threshold. In each session, a 2-s train of bursts will be repeated every 10 s for a total of 570 s (1800 pulses) to the left dorsolateral prefrontal cortex (DLPFC). TBS sessions will be scheduled daily in a 5-day sequence, for a total of 10 sessions in 2 weeks.

experimental (iTBS group)

sham repetitive transcranial magnetic stimulation (rTMS) DEVICE

no stimulation, Sham TBS sessions will be scheduled daily in a 5-day sequence, for a total of 10 sessions in 2 weeks.

sham group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The Chinese Version of Modified Schedule of Affective Disorder and Schizophrenia-Life Time (SADS-L) and DSM-IV-TR will be conducted for confirmation of the diagnosis of BD-II.
• Aged 20-65.
• HDRS and YMRS will be used to evaluate severity of mood symptoms. Only patients in deressive state (HDRS≧18) will be recruited.

You may not qualify if:

• Any DSM-IV-TR Axis I diagnosis, including organic mental disorders, substance use disorder, and other major and minor mental illnesses other than BD-II.
• Any significant medical illness.
• Any neurological disorders.
• Any poorly controlled physical illness that might influence the interview and study results.
• Any form of metal implants.
• Any history of seizures, or medications known to lower seizure threshold.
• History of exposure to TMS or electroconvulsive therapy.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

KaohsiungVGH

Kaohsiung City, 813, Taiwan

RECRUITING

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MeSH Terms

Conditions

Bipolar Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician, Department of Psychiatry, Kaohsiung Veterans General Hospital

Model Details: one experimental and one sham group

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 10, 2021
• Study Start: May 23, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)