Mild to moderate depression Mental and Behavioural Disorders
Conditions
Interventions
This study is a prospective, multi-center, double-blinded, randomized controlled trial (RCT) with two parallel arms: XYM group and placebo group. The trial will recruit 72 patients with MMD from 4 hos
Sponsors
Jinan University
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) with a HAMD-17 score between 7 and 24 points. 2. Meet the diagnosis criteria for liver depression and spleen deficiency syndrome; 3. Patients aged 16-65 years, regardless of gender; 4. Patients are voluntary, have informed consent, and have good compliance.
Exclusion criteria
Exclusion criteria: 1. Patients with bipolar depression, refractory depression, or suicidal tendency (item 3 score of HAMD scale > 2 points); 2. Patients with other mental disorders such as organic mental disorders, schizophrenia, depression disorders caused by psychoactive substances and non-addictive substances; 3. Patients with severe organ lesions such as heart, liver and kidney, hematological diseases or tumors; 4. Patients who have received systematic treatment within 2 weeks before enrollment; 5. Pregnant or lactating women, or those who require fertility during the trial; 6. Patients who are participating in other clinical trials or have participated in other drug clinical trials within 3 months before screening; 7. Patients with a known or suspected allergy to the investigational drugs and excipients, or hypersensitivity constitution (defined as allergy to at least 2 drugs); 8. Patients who used fluoxetine within 4 weeks before enrollment; 9. Other situations that the researchers consider unsuitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression severity measured using Hamilton Depression Rating Scale at baseline, Week 1, Week 2, Week 4 and Week 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anxiety levels measured using Hamilton Anxiety Rating Scale at Week 1, Week 2, Week 4, and Week 6. 2. Anhedonia assessed with Dimensional Anhedonia Rating Scale at Week 1, Week 2, Week 4, and Week 6. 3. Pleasure experience measured using Temporal Experience of Pleasure Scale at Week 1, Week 2, Week 4, and Week 6. 4. Quality of life satisfaction gauged with Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Week 1, Week 2, Week 4, and Week 6. 5. Somatic symptoms measured using Patient Health Questionnaire-15 at Week 6. 6. Sleep quality assessed with Pittsburgh Sleep Quality Index at Week 6. 7. Global functioning evaluated with Clinical Global Impression scale at Week 1, Week 2, Week 4, and Week 6. 8. Traditional Chinese Medicine syndrome evaluated with Liver Depression and Spleen Deficiency Syndrome score at Week 1, Week 2, Week 4, and Week 6. | — |
Countries
China
Contacts
Public Contactxuan ZHOU
Outcome results
None listed