Post-partum DepressionNCT01178008
Pilot Study on the Use of Acupuncture for Postpartum Depression
A study testing Active acupuncture in people with Post-partum Depression, run by The University of Hong Kong at 3 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-partum Depression
- What is being tested?
- Active acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesHong Kong
- Study dates
- May 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Kwong Wah Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Tsan Yuk Hospital
Hong Kong
About this study
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.
Read the 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.
- Conditions
- Post-partum Depression
- Being tested
- Active acupuncture, Placebo acupuncture
- Keywords
- Insomnia, Post-partum Depression, Electroacupuncture, Acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine
- Medical subject headings
- Depression, Postpartum, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active acupunctureProcedure or surgery
Also called Electroacupuncture
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.
Placebo acupunctureProcedure or surgery
Also called Streitberger needles, Non-invasive acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| Active acupuncture group | Experimental | Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints. Receives: Procedure: Active acupuncture |
| Placebo acupuncture group | Placebo comparator | 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. Receives: Procedure: Placebo acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item Hamilton Depression Rating Scale
To assess Depressive symptoms
Measured: 8 weeks
Secondary outcomes (4)
Hospital Anxiety and Depression Scale (HADS)
To assess depression and anxiety
Measured: 8 weeks
Sheehan Disability Scale
To assess subjects' functioning in work/study, social life and family
Measured: 8 weeks
Clinical Global Impression Scale
To assess severity of illness and improvement due to treatment
Measured: 8 weeks
Edinburgh Postnatal Depression Scale
To assess subjective Depressive symptoms
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-partum DepressionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Kwong Wah Hospital, Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Dr. Chung Ka-Fai, The University of Hong Kong
- Investigators
- Ka-Fai CHUNG, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178008
- Sponsor's protocol ID
- Acup-003
- Status last verified
- Jan 2013
- First submitted
- 1 Aug 2010
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 3651732HAMILTON 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.
PubMed 14399272Chung 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.
PubMed 22840621
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Use of Acupuncture for Postpartum Depression
- ClinicalTrials.gov ID
- NCT01178008
- Acronym / sponsor ID
- Acup-003
- Conditions
- Post-partum Depression
- Keywords
- Insomnia, Post-partum Depression, Electroacupuncture, Acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Kwong Wah Hospital, Hospital Authority, Hong Kong
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active acupuncture group | Experimental | Procedure: Active acupunctureActive acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints. |
| Placebo acupuncture group | Placebo comparator | Procedure: Placebo acupunctureStreitberger'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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active acupunctureAlso: ElectroacupunctureActive 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. | Procedure or surgery | Active acupuncture group |
| Placebo acupunctureAlso: Streitberger needles, Non-invasive acupunctureStreitberger'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. | Procedure or surgery | Placebo acupuncture group |
Primary outcome
17-item Hamilton Depression Rating Scale
Time frame: 8 weeks
To assess Depressive symptoms
4 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 8 weeks
Sheehan Disability Scale
Time frame: 8 weeks
Clinical Global Impression Scale
Time frame: 8 weeks
Edinburgh Postnatal Depression Scale
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Background: PubMed 3651732Cox 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.
- Background: PubMed 14399272HAMILTON 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.
- Derived from this study: PubMed 22840621Chung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka-Fai CHUNG, MBBS principal investigator
The University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active acupuncture in people with Post-partum Depression, run by The University of Hong Kong at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17-item Hamilton Depression Rating Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01178008, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.