Depressive Disorder Clinical Trial
Official title:
Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Depressive Disorder
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on suicidal ideation and somatic symptoms in patients with depressive disorder and its underlying neural mechanism by MRI.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD>17, BSS>6, PHQ-15>5. - the age ranged from 18 to 60 years old, and the length of education was more than 5 years. - the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests. Exclusion Criteria: - accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on. - accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women. - accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective disorder, hysteria, autism and so on. - patients with MRI taboos or factors affecting imaging quality, such as cardiac pacemaker, cochlear implant, cardio-cerebrovascular metal stent, metal denture, etc. - those who could not cooperate with those who completed the relevant xperiments, such as patients with depressive stupor, claustrophobia and so on. |
Country | Name | City | State |
---|---|---|---|
China | Anhui Medical University | Hefei |
Lead Sponsor | Collaborator |
---|---|
Anhui Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of depression symptoms of active teatment group | the change of depressive symptoms were assessed by HAMD scale. | baseline and immediately after the intervention | |
Primary | change of risk of suicide of active teatment group | the change of risk of suicide was assessed by Beck scale for suicide ideation. | baseline and immediately after the intervention | |
Primary | change of somatization symptoms of active teatment group | the change of somatization symptoms were assessed by PHQ- 15 scale. | baseline and immediately after the intervention | |
Primary | change of depression symptoms of sham treatment group | the change of depressive symptoms were assessed by HAMD scale. | baseline and immediately after the intervention | |
Primary | change of risk of suicide of sham treatment group | the change of risk of suicide was assessed by Beck scale for suicide ideation. | baseline and immediately after the intervention | |
Primary | change of somatization symptoms of sham treatment group | the change of somatization symptoms were assessed by PHQ- 15 scale. | baseline and immediately after the intervention | |
Primary | Functional MRI measures | the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures. | baseline | |
Primary | Functional MRI measures | the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures. | immediately after the intervention |
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