Major Depressive Disorder
Conditions
Interventions
Placebo Control Group:Placebo Group: Orally administered capsules containing corn oil once daily for a total duration of 8 weeks.
Both investigators (including the principal investigator, outcome asse
participants took 2 capsules daily (total 420mg/day).
Placebo capsules contained corn oil, matching POA capsules in size, color, and dosing frequency (2 capsules/day).
A random sealed code system was
POA Group:POA Group: Oral administration of capsules containing a total daily dose of 420 mg pure POA, taken once daily for 8 weeks.
Rationale for Dose Selection (with reference to):
720 mg/day POA
Sponsors
The Affiliated Brain Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Inclusion Criteria: 1 Males and females aged 18-45 years; 2 Meeting DSM-5 diagnostic criteria for depressive disorder as confirmed by the SCID-5 screening tool; 3 Mild-to-moderate severity, with a total score of 8-17 on the 17-item Hamilton Depression Rating Scale (HAMD-17); 4 Completion of primary education or higher; 5 Understanding the study content, willingness to participate, and provision of written informed consent.
Exclusion criteria
Exclusion criteria: (2) Exclusion Criteria: 1 Diagnosis of other mental disorders per DSM-5 criteria, including but not limited to organic mental disorders, alcohol dependence, drug dependence/abuse, schizophrenia, bipolar disorder, attention-deficit/hyperactivity disorder (ADHD), eating disorders, and obsessive-compulsive disorder; 2 History of suicidal behavior within the past six months or current active suicidal ideation/behavior (suicide item score >2 on HAMD-17) that may pose risks for clinical trial participation; 3 Clinically significant uncontrolled or unstable systemic diseases affecting cardiovascular, renal, hepatic, gastrointestinal, hematologic, immunologic, endocrine, metabolic, or respiratory systems; 4 Positive serum/urine pregnancy test, current lactation, or planned pregnancy during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD-17; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function;MRI;WHOQOL-BREF;Electrocardiogram ;PHQ;PSQI;SDS; | — |
Countries
China
Contacts
Public ContactZHOUYANLING
The Affiliated Brain Hospital of Guangzhou Medical University
Outcome results
None listed