Major depressive disorder, Bipolar II disorder
Conditions
Interventions
Five sessions for 5 consecutive days:The iTBS protocol was delivered at 80% of the resting motor threshold (RMT), consisting of triplet bursts at 50 Hz, repeated at 5 Hz (2 seconds on and 8 seconds of
Ten sessions for 5 consecutive days:The iTBS protocol was delivered at 80% of the resting motor threshold (RMT), consisting of triplet bursts at 50 Hz, repeated at 5 Hz (2 seconds on and 8 seconds off
Sponsors
the Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) age between 18 and 60 years old; (2) at least a junior high school education and be able to read and understand consent forms and questionnaires independently; (3)right-handedness; (4) currently experiencing a depressive episode as part of either major depressive disorder (MDD) or bipolar II disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with the diagnosis confirmed by two psychiatrists who had received consistency training using the Structured Clinical Interview for DSM-5; (5) having a Hamilton depression Rating Scale (HAMD) score = 17 at screening; (6) receiving a stable antidepressant medication regimen for = 8 weeks before screening and have not responded to at least one adequate antidepressant trial;
Exclusion criteria
Exclusion criteria: 1. Any lifetime psychiatric disorder other than MDD and bipolar II disorder; 2. Current severe suicidal ideation or recent suicide attempt; 3. Organic brain diseases or serious systemic diseases (including rheumatic immune system diseases, endocrine and metabolic diseases, and nervous system diseases); 4. Contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG); 5. Color blindness or inability to complete neurocognitive testing; 6. Pregnancy or breastfeeding; 7. A positive urine drug screen or abnormal thyroid function tests; 8. Having a history of seizure; 9. Receiving physical therapies such as electroconvulsive therapy or rTMS within six month; 10. Alcohol or substance dependence; 11. Receiving anticoagulants (e.g. heparin, warfarin), glucocorticoids, or treatment for thyroid diseases within the past 3 months; 12. Having used psychoactive substances (e.g.,cocaine); 13. Receiving similar neurocognitive assessment within the past 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HAMD-17 scores between time point; | — |
Secondary
| Measure | Time frame |
|---|---|
| remission rate;response rate;Montgomery-Asberg Depression Rating Scale;Hamilton Rating Scale For Anxiety;9-item Patient Health Questionnaire, PHQ-9;Beck Scale for Suicide Ideation;Concise Health Risk Tracking Scale, CHRT-SR;Neuropsychological cognitive function tests;The Inventory of Depressive Symptomatology;Snaith-Hamilton Pleasure Scale;Athens Insomnia Scale;Connor-Davidson resilience scale;Perceived Stress Scale;Concise Associated Symptoms Track,, CAST-SR;Generalized Anxiety Disorder-7, GAD-7;Adverse Event Record Form,AERF; | — |
Countries
China
Contacts
Public ContactLingjiang Li
the Second Xiangya Hospital of Central South University
Outcome results
None listed