- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01178008
Pilot Study on the Use of Acupuncture for Postpartum Depression
January 14, 2013 updated by: Dr. Chung Ka-Fai, The University of Hong Kong
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 hypothesis is that active acupuncture would be superior to placebo acupuncture in the short-term treatment of postpartum depression.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 acupuncture.
The subjects will receive acupuncture treatment twice per week for 4 consecutive weeks.
The acupuncturist of this trial will not participate in data collection and data entry.
The trial assessor will be blind to the subjects' treatment allocation.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Hong Kong, Hong Kong
- Kwong Wah Hospital
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Hong Kong, Hong Kong
- Tsan Yuk Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Active acupuncture group
Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints.
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Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints which are empirical for treating depression in term of traditional Chinese medicine theory.
It is done by a registered Chinese medicine practitioner with at least 3 years experience of providing acupuncture treatment.
An electric-stimulator is connected to these needles to give an electric-stimulation in a continuous wave The needles will be left for 30 min and then removed.
Acupuncture treatment will consist of two sessions per week for 4 consecutive weeks.
Other Names:
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Placebo Comparator: Placebo acupuncture group
Streitberger's non-invasive acupuncture needles will be applied to serve as placebo control at the same acupoints and the same stimulation modality, except that the needles only affixed on the skin with adhesive tapes instead of insertion.
Since all the points used are beyond patients' vision as they lay on bed, they could not visualize the acupuncture procedure.
The acupuncturist, setting, treatment frequency, and duration of the treatment course are the same as the active acupuncture group.
|
Streitberger's non-invasive acupuncture needles will be applied to serve as placebo control at the same acupoints and the same stimulation modality, except that the needles only affixed on the skin with adhesive tapes instead of insertion.
Since all the points used are beyond patients' vision as they lay on bed, they could not visualize the acupuncture procedure.
The acupuncturist, setting, treatment frequency, and duration of the treatment course are the same as the active acupuncture group.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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17-item Hamilton Depression Rating Scale
Time Frame: 8 weeks
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To assess Depressive symptoms
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: 8 weeks
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To assess depression and anxiety
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8 weeks
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Sheehan Disability Scale
Time Frame: 8 weeks
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To assess subjects' functioning in work/study, social life and family
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8 weeks
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Clinical Global Impression Scale
Time Frame: 8 weeks
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To assess severity of illness and improvement due to treatment
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8 weeks
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Edinburgh Postnatal Depression Scale
Time Frame: 8 weeks
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To assess subjective Depressive symptoms
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
- Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Chung KF, Yeung WF, Zhang ZJ, Yung KP, Man SC, Lee CP, Lam SK, Leung TW, Leung KY, Ziea ET, Taam Wong V. Randomized non-invasive sham-controlled pilot trial of electroacupuncture for postpartum depression. J Affect Disord. 2012 Dec 15;142(1-3):115-21. doi: 10.1016/j.jad.2012.04.008. Epub 2012 Jul 26.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
August 1, 2010
First Submitted That Met QC Criteria
August 6, 2010
First Posted (Estimate)
August 9, 2010
Study Record Updates
Last Update Posted (Estimate)
January 16, 2013
Last Update Submitted That Met QC Criteria
January 14, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acup-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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