NCT05929183

Brief Summary

The purpose of this study is to explore a new stimulation target and protocol for the treatment of depressive episode in adolescents with bipolar disorder through the repetitive transcranial magnetic stimulation(rTMS) under neuronavigation, and verify whether there is abnormal functional connectivity between the emotion-related brain area orbital frontal lobe (OFC) and the primary visual cortex(V1) during the depressive episode, which will contribute to further understand the relevant neural pathway and mechanism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

June 26, 2023

Last Update Submit

September 23, 2025

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Montgomery-Asberg Depression Rating Scale（MADRS）

    Montgomery-Asberg Depression Rating Scale (MADRS) is used to reflect the effect of antidepressant treatment and monitor the change of patients' condition. The scale is a separate scale, and the score should be based on clinical interviews. The symptoms should be asked from broad to detailed, so as to accurately score the severity. The rater must determine whether the score is on the defined score values (0,2,4,6) or between these scores (1,3,5), according to clinical practice. The scale can be used to score at any time interval.

    0-8 weeks

Study Arms (2)

Repetitive Transcranial magnetic stimulation

ACTIVE COMPARATOR
Device: Repetitive Transcranial magnetic stimulation

Sham Repetitive Transcranial magnetic stimulation

SHAM COMPARATOR
Device: Sham Repetitive Transcranial magnetic stimulation

Interventions

Repetitive Transcranial magnetic stimulationDEVICE

Setting up a new target for rTMS. In the past research, the common target of rTMS in the treatment of depressive symptom was dorsolateral prefrontal cortex (DLPFC). In this study, we use high frequency rTMS in the occipital lobe are precisely targeted by navigation, by stimulating the primary visual cortex（V1), can affect the orbitofrontal cortex (OFC), which is functionally connected to V1, and thus affect the entire nerve ring pathway excitability, thereby rapidly, effectively and safely improving mood symptoms in the acute phase of bipolar depressive episode. After the target was determined by fMRI navigation and positioning, the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000.

Repetitive Transcranial magnetic stimulation
Sham Repetitive Transcranial magnetic stimulationDEVICE

The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters were the same as the Active Comparator arm.

Sham Repetitive Transcranial magnetic stimulation

Eligibility Criteria

Age14 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 14-28 years old, regardless of gender;
  • Meet DSM-V diagnostic criteria for bipolar depressive episodes;
  • Young Mania Rating Scale (YMRS) ≤ 6 points;
  • MARDS:12-30 points.
  • Han nationality, right-handed;
  • More than 9 years of education.

You may not qualify if:

  • History of severe somatic or brain organic diseases and craniocerebral trauma;
  • Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
  • Those who do not cooperate or cannot effectively complete the experiment;
  • Drug, alcohol or other psychoactive substance abusers;
  • Pregnant, lactating or planned pregnancy.
  • Severe suicidal ideation and behavior
  • ECT or rTMS treatment was performed within six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 3, 2023

Study Start

September 1, 2022

Primary Completion

June 30, 2023

Study Completion

July 1, 2023

Last Updated

September 26, 2025

Record last verified: 2023-09

Locations

CN(1)