Status:
COMPLETED
Pilot Study on the Use of Acupuncture for Postpartum Depression
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Kwong Wah Hospital
Hospital Authority, Hong Kong
Conditions:
Post-partum Depression
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The proposed study is a randomized controlled trial to examine the efficacy and safety of active acupuncture versus placebo acupuncture for the treatment of postpartum depression. The investigators hy...
Detailed Description
This study will be a randomized, controlled, subject- and assessor-blind trial in patients with postpartum depression. Eligible subjects will be randomly assigned to active acupuncture or placebo acup...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01178008
Start Date
May 1 2010
End Date
June 1 2012
Last Update
January 16 2013
Active Locations (3)
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1
Kwong Wah Hospital
Hong Kong, Hong Kong
2
Queen Mary Hospital
Hong Kong, Hong Kong
3
Tsan Yuk Hospital
Hong Kong, Hong Kong