Depression Mental and Behavioural Disorders Depression
Conditions
Interventions
Participants are randomly assigned to one of two groups: SSRIs alone (control group) or combined with cupping therapy (treatment group).
Control group: Participants will receive SSRIs
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of depression using the International Classification of Disease (10th version) (ICD-10) 2. Aged 18-65 years 3. Moderate or severe depression with a score of =17 on HAMD-17 4. Current treatment with SSRIs or no medication 5. No cupping therapy during the previous 2 weeks 6. Patients agree to participant in this trial and assign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Difficulty in communication 2. Severe suicidal risk (HAMD-17 suicidal item score=4) 3. History of dementia 4. History of bipolar disorder, schizophrenia or have obvious psychotic symptoms. 5. History of alcohol or drug abuse within 12 months 6. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate defined as =50% reduction from baseline on 17-item Hamilton Rating Scale for Depression (HAMD-17 measured at 8 weeks (endpoint) and 24 weeks (follow-up point). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in HAMD-17 score from baseline at weeks 2, 4, 8 (endpoint) and week 24 (follow-up). 2. Change from baseline in each of five factor scores on HAMD-17 score from baseline at weeks 2, 4, 8 (endpoint) and week 24 (follow-up). 3. Safety and tolerability measured by Treatment Emergent Symptom Scale (TESS) when patients visit the doctor. | — |
Countries
China
Outcome results
None listed