Depression Mental and Behavioural Disorders Depression
Conditions
Interventions
This is a six-week, single-blind, randomised, sham controlled study. A total of 66 untreated patients with MDD will be recruited. Under single-blind condition, patients will be randomly assigned to pa
Sponsors
The Health and Health Services Research Fund (HHSRF), Food and Health Bureau of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Either gender aged 25 - 65 years 2. Have first-episode major depressive disorder (MDD) diagnosed from the diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV) 3. Scores on the 17-item Hamilton depression rating scale (HAMD) and clinical global impression of severity (CGI-S) are at least 20 and 4 points, respectively 4. Have not yet received any psychoactive medications
Exclusion criteria
Exclusion criteria: 1. Unstable medical conditions 2. Have suicidal attempts or aggressive behaviour 3. Previously experienced manic, hypomanic, or mixed episode 4. Immediate family members were or are diagnosed for bipolar or psychotic disorders 5. Treatment with investigational drugs in past six months 6. Alcoholism or drug abuse in past one year 7. Have needle phobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Efficacy, measured using the HAMD-17, CGI-S, and Sheehan disability scale (SDS) 2. Adverse events, assessed using the treatment emergent symptom scale (TESS) Assessments will be conducted at baseline and at day 3, 7, 10, 14, 21, 28, 35, and 42. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical response, defined as less than 50% reduction from baseline on HAMD-17 2. Remission, defined as a score 7 points or less on the HAMD-17 Assessments will be conducted at baseline and at day 3, 7, 10, 14, 21, 28, 35, and 42. | — |
Countries
China, Hong Kong
Outcome results
None listed