Major depressive disorder with anxious distress
Conditions
Interventions
active treatment group:High-definition transcranial direct current stimulation
Sponsors
Zhenjiang Mental Health Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Ability and willingness to provide written informed consent to participate in the trial and undergo all necessary procedures; 2. Age from 18 to 65 years; 3. A diagnosis of MDD with ADS according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), which is assessed by at least one professional psychiatrist; The presence of the specifier was assessed according to the criterion of the DSM-5, requiring that the MDD patient presents/fulfills at least 2 of 5 the symptoms; 4. Han ethnicity; 5. Right-handedness; 6. Adequate auditory and visual ability to complete the necessary checks; 7. Presence of mild to severe levels of depressive symptoms measured and defined by HAMD-17 scores >= 8 and <= 52; 8. Willing to remain on maintenance pharmacotherapy for at least 2 weeks before the stimulation initiation and during the total stimulation period.
Exclusion criteria
Exclusion criteria: 1. The presence of severe systemic illnesses including, but not limited to severe hepatic, renal, endocrine, cardiovascular, respiratory, hematological, or oncological diseases, deemed by the investigator to be unsuitable to allow participation in the trial; 2. Any clinically significant abnormal laboratory examination that may influence the health of participants in the opinion of the investigator; 3. A history of any significant medical illness such as neurological disorders (e.g.: cerebral trauma, seizure disorder, etc), which in the opinion of the investigator would preclude safe participation in the trial; 4. Known with current psychosis as determined by the DSM-5; or a history of a non-mood psychotic disorder; 5. Current alcohol and/or any illicit or legal drug abuse; 6. Current or planned pregnancy and/or lactation during the trial; 7. An abnormal scalp such as open wounds; 8. A score=4 for item 3 (suicide) on the HDRS-17; 9. Having had or currently receiving modified electroconvulsive therapy (MECT) or repetitive transcranial magnetic stimulation (rTMS) in the past 1 month; 10. Participation in another clinical trial concurrently or less than 1 month prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| variation of possible anxiety symptoms;Disability assessment/daily functioning; | — |
Countries
China
Contacts
Public ContactDanwei Zhang
Zhenjiang Mental Health Center
Outcome results
None listed