Depressive Disorder Clinical Trial
Official title:
Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) Assisted Electroconvulsive Therapy (ECT) for Depression Disorder
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) assisted Electroconvulsive Therapy (ECT) for depressive disorder.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
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. - Meets the ECT treatment indication - 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. - with a history of ECT treatment within the past 3 months |
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 in Hamilton Depression Rating Scale (HAMD) Score | The HAMD is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. | baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention) | |
Primary | Change in Associative Memory | The associative memory was estimated using a face-cued word association test. In the face-cued word association test, participants studied 12 human face photographs presented individually in grayscale on a computer screen for 4 s per face. Each photograph displayed a unique common word that the participants read aloud as each face-word pair was shown. The participants were instructed to memorize the word associated with each face. After the face-word pairs were presented, participants were shown the same 12 faces, individually and in a different and randomized order. They were asked to recall the words that were presented with each face. Each face was scored as correct or incorrect.These processes are carried out 2 times in total.The average number of successful answers was defined as the associative memory score. | baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention) | |
Secondary | Change in Hamilton Anxiety Scale (HAMA) Score | The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms. | baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention) | |
Secondary | Change in the Patient Health Questionnaire-15 (PHQ-15) scale | The PHQ-15 is a 15-item scale to measure the severity of somatic symptoms, where each item is rated on a scale from 0 to 2. The PHQ-15 total score ranges from 0 to 30, with lower scores indicating less somatic symptoms. | baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention) | |
Secondary | Change in Working Memory | The n-back task is one of the most common tasks in working memory studies, involving the storage and manipulation of information. In the 2-back condition, they were required to press a button when the current stimulus matched the stimulus from two trials back; in the 1-back condition, participants pressed a button if the current stimulus matched the immediately preceding stimulus.The n-back task consisted of two block-design functional runs, each of which lasted 336 s.Each run included four block sets, where the 1-back and 2-back conditions were intermixed. The order of blocks in each run was pseudorandomized across participants.The average correct rate in the two conditions was used as an indicator of working memory. | baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention) |
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