Depressive symptoms
Conditions
Interventions
Intervention group:Take 2 Jerusalem artichoke extract tablets (150mg) daily (1 tablet at a time)
Control group:Take 2 placebo pills (150mg) daily (one pill at a time)
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Individuals aged 18 to 50 years (inclusive), of any gender or ethnicity; (2) HAMD-17 score between 14 and 24 at both screening and baseline visits; (3) Agree to use effective contraception during the trial and for 30 days after the last dose of the study product (female participants of childbearing potential must have a negative pregnancy test before taking the study product and must not be breastfeeding), and male participants must have no plans to donate sperm, while female participants must have no plans to donate oocytes; (4) Voluntarily agree to participate in the trial and provide written informed consent.
Exclusion criteria
Exclusion criteria: (1) Current or past history of psychiatric disorders such as manic/hypomanic episodes, bipolar and related disorders, schizophrenia, or the presence of psychotic symptoms; (2) Use of any contraindicated combination therapy or medications that may interfere with treatment effects, including the use of antidepressants, antipsychotics, or mood stabilizers within at least 14 days prior to enrollment; (3) Total score on the Young Mania Rating Scale (YMRS) >12 during the screening/baseline period; (4) Current or past history of epileptic seizures, or suffering from other severe or unstable cardiovascular, respiratory, hepatic, renal, endocrine, hematologic, or other systemic diseases deemed by the investigator as unsuitable for study enrollment; (5) Pregnant or breastfeeding women; (6) Infection and/or vaccination and/or antibiotic treatment within the past month; (7) Use of probiotics or prebiotics within the past month; (8) Systematic treatment with modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), or other physical therapies, as well as light therapy, music therapy, exercise therapy, acupuncture, and other treatments within three months prior to enrollment (e.g., completion of a full MECT course within three months, which typically includes 6–12 sessions); (9) Diagnosed with or experiencing new autoimmune symptoms, severe immunodeficiency, inflammatory bowel disease, diabetes, inflammation, tumors, or other structural abnormalities of the digestive system; (10) IgE-dependent allergies within the past month, or a history of allergy or ineffectiveness to any component of our product; (11) Use of sleep medications within the past month or ongoing use (including benzodiazepines, non-benzodiazepine medications, melatonin receptor agonists, etc.); (12) Significant changes in dietary patterns or dietary supplements within the past month; (13) Significant changes in daily physical activity or engagement in extreme exercise within the past month; (14) Investigator assessment of suicide risk in the past 6 months or currently (history of suicide; current high suicide risk or suicidal tendencies; C-SSRS ideation score >=3); (15) Investigator judgment of any condition affecting food swallowing or absorption; (16) Abnormal physical examination or laboratory test findings at screening or baseline deemed clinically significant by the investigator, including but not limited to alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or serum creatinine exceeding 1× the upper limit of normal. (17) Conditions or diseases that, in the judgment of the investigator, may increase trial risk, affect participants' adherence to the protocol, or impact their ability to complete the trial, either physiologically or psychologically; (18) Participation in another study during the current time or within the past three months that involves interventions potentially related to the outcomes of this study; (19) Any comorbid condition that may interfere with the trial procedures or assessments, or any situation deemed by the investigator as unsuitable for inclusion in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale - 17 Items; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale;Quick Inventory of Depressive Symptomatology Self-Report (16-item);Generalized Anxiety Disorder 7-item;Patient Health Questionnaire-9;Young Mania Rating Scale;Columbia Suicide Severity Rating Scale;Pittsburgh Sleep Quality Index; | — |
Countries
China
Contacts
Public ContactLi Anning
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed