Efficacy and Safety Study of Neuronavigation Occipital rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- First Affiliated Hospital of Zhejiang University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Montgomery-Asberg Depression Rating Scale（MADRS）
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Hu ShaoHua
Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University
First Affiliated Hospital of Zhejiang University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Montgomery-Asberg Depression Rating Scale（MADRS）
Time Frame: 0-8 weeks
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.