Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01178008
Eligibility Criteria:
Inclusion Criteria:
* Ethnic Hong Kong Chinese aged 18 years or above;
* Within 6 months of giving birth;
* Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987) score higher than or equal to 12 or being diagnosed as depressed by their obstetrician;
* Meeting the Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis criteria for major depressive disorder;
* 17-item Hamilton Depression Rating Scale (HDRS17) (Hamilton, 1960) score of between 12 and 19 at screening and baseline assessment;
* Willingness to give informed consent and comply with trial protocol.
Exclusion Criteria:
* Suffering from other psychiatric disorders such as schizophrenia, other psychotic disorders, bipolar disorder or substance use disorder;
* Serious physical illnesses or mental disorders due to a general medical condition which are judged by the investigator to render unsafe;
* A significant risk of suicide according to the rating of HDRS17 item 3 (score higher than 2), i.e., presence of ideas or gesture of suicide;
* A presence of idea of self-harming according to the rating of EPDS item 10 (score higher than 0);
* A significant risk of infanticide according to the investigator assessment;
* Any acupuncture treatment during the previous 12 months prior to baseline;
* Valvular heart defects, bleeding disorders or taking anticoagulant drugs;
* Infection or abscess close to the site of selected acupoints;
* Herbal remedies or psychotropic drugs that are intended for depression are taken within the last 2 weeks prior to baseline or during the study.
* Receiving counseling or psychological therapies at baseline or during the study;
* Participation in any clinical trial within the previous 3 months prior to baseline;
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01178008
Study Brief:
Protocol Section:
NCT01178008