DepressionNCT05452746
Acupuncture Augmentation for Inpatients With Major Depression Disorder
A study testing Acupuncture and Treatment as usual in people with Depression, run by Institute of Mental Health, Singapore at 1 site in Singapore.
Trial summary
Acupuncture practice is based on Traditional Chinese Medicine (TCM) principles of harmonization and balance, and the need to maintain unobstructed flow of energy (Qi) to attain efficient body functioning and metabolism so as to attain good mental and physical state of health. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Acupuncture and Treatment as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Jun 2022to 31 May 2025
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥21 years.
- DSM-V diagnosis of current Major Depressive Episode.
- Montgomery-Asberg Depression Rating Scale score of 20 or more.
- Able to give informed consent.
Who cannot join
- History of psychosis or mania
- With current ECT or neurostimulation treatment.
- With severe heart or renal condition
- Currently taking blood thinning drug including Aspirin etc.
- Endocrine abnormalities (e.g., hypothyroidism, unstable diabetes);
- History of central nervous system involvement (e.g., seizures, brain injury, neurologic ill- ness);
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Institute of Mental Health
Singapore, 539747
Phern Chern Tor, MBBS
About this study
Official title: Acupuncture Augmentation Therapy for In-hospital Patients With Major Depression Disorder: a Pragmatic, Randomized Controlled Trial
Acupuncture practice is based on Traditional Chinese Medicine (TCM) principles of harmonization and balance, and the need to maintain unobstructed flow of energy (Qi) to attain efficient body functioning and metabolism so as to attain good mental and physical state of health. While increasing numbers of patients are seeking acupuncture treatment for depression in recent years, there is limited evidence of the effectiveness of acupuncture for in-hospital patients with severe depressive conditions and comorbid cognitive dysfunction, who need intensive antidepression care.
In this study, we propose a randomized clinical trial to test the clinical efficacy of acupuncture treatment for in-hospital patients who are suffering from major depressive disorder. A total of 84 patients will be 1:1 randomly assigned to 1 of 2 groups in a single-blind randomized controlled trial. The specific intervention arm involved daily augmentation TCM-style acupuncture with manual stimulation for total 10 sessions; the control arm is consisted of patients with treatment as usual (TAU), i. e. waitlist condition who will receive standard antidepressant medication with or without psychotherapies. Patients in TAU arm will be offered one free course (total 10 sessions) of acupuncture treatment in TCM outpatient clinic after they have been discharged from the ward. All patients' depressive symptoms, cognitive function, quality of life and functioning will be assessed and compared at pre-treatment (baseline), immediately after in-hospital acupuncture treatment, one-month post-treatment and 3-month post-treatment. In addition, we will analyze the association of sociodemographic and clinical characteristics with the treatment effect of acupuncture.
This study will be the first study to examine whether acupuncture is a viable augmentation treatment for in-hospital patients with depression. Expected outcomes will include determining the relative short and medium-term clinical effects from the most commonly used acupuncture treatment modalities in a local and multiethnic population.
- Conditions
- Depression
- Being tested
- Acupuncture, Treatment as usual
- Keywords
- Acupuncture
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Unilateral and bilateral acupuncture points:
Du 20 and GV 29,39 MS1, MS2, MS3 and MS4,40
Location of points:
Number of needles: 9
Depth of insertion:
MS1, MS2, MS3: insert the needle obliquely in the frontal direction for 1 cm Du 20: insert the needle obliquely in the frontal direction for 0.5 cm GV 29: insert the needle obliquely and downward for 0.5 cm Needles retained for 20 min Needle type: Han Yi 0.25x25 mm Treatment regimen: once per day for 2 weeks
Treatment as usualOther
Inpatient psychiatric care for depression
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Not described Receives: Device: Acupuncture |
| Treatment as usual | Active comparator | Not described Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorder (scored 0 to 60 with higher scores meaning worse outcome)
Measured: 2 week post treatment
Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.(scored 0 to 60 with higher scores meaning worse outcome)
Measured: 1 month post treatment
Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.(scored 0 to 60 with higher scores meaning worse outcome)
Measured: 3 months post treatment
Secondary outcomes (5)
Montreal Cognitive Assessment (MoCA) (clinician administered).
MoCA was validated in the setting of mild cognitive impairment,44 and has subsequently been adopted in numerous other settings clinically. (scored 0 to 30 with higher scores indicating better outcome)
Measured: 2 weeks, 1 month, 3 months post treatment
EQ-5D (self-administered)
EQ-5D is a standardized measure of health-related QoL developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys
Measured: 2 weeks, 1 month, 3 months post treatment
Quick Inventory of Depressive Symptomatology- Self report 16 items (QIDS-SR16) (subjective, self-administered)
The QIDS-SR16 has highly acceptable psychometric properties, which supports the usefulness of this brief rating of depressive symptom severity in both clinical and research settings
Measured: 2 weeks, 1 month, 3 months post treatment
Global Assessment of Functioning (GAF) (clinician administered)
GAF is a scoring system that mental health professionals use to assess how well an individual is functioning in their daily lives (Scored 0-100 with higher score indicating better outcomes)
Measured: 2 weeks, 1 month, 3 months post treatment
TCM Assessment Form (Depression)
Measured: 2 weeks, 1 month, 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start24 Jun 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Model description
- Randomized single blinded controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mental Health, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University
- Responsible party
- Sponsor
- Investigators
- Phern Chern Tor, MBBS, Principal investigator, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452746
- Sponsor's protocol ID
- IMHSingapore
- Status last verified
- Jul 2022
- First submitted
- 24 Jun 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Augmentation Therapy for In-hospital Patients With Major Depression Disorder: a Pragmatic, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05452746
- Acronym / sponsor ID
- IMHSingapore
- Conditions
- Depression
- Keywords
- Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Institute of Mental Health, SingaporeUniversity, hospital or other
- Collaborators
- Nanyang Technological University
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 11 Jul 2022 (actual)
- 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.
Acupuncture practice is based on Traditional Chinese Medicine (TCM) principles of harmonization and balance, and the need to maintain unobstructed flow of energy (Qi) to attain efficient body functioning and metabolism so as to attain good mental and physical state of health. While increasing numbers of patients are seeking acupuncture treatment for depression in recent years, there is limited evidence of the effectiveness of acupuncture for in-hospital patients with severe depressive conditions and comorbid cognitive dysfunction, who need intensive antidepression care.
In this study, we propose a randomized clinical trial to test the clinical efficacy of acupuncture treatment for in-hospital patients who are suffering from major depressive disorder. A total of 84 patients will be 1:1 randomly assigned to 1 of 2 groups in a single-blind randomized controlled trial. The specific intervention arm involved daily augmentation TCM-style acupuncture with manual stimulation for total 10 sessions; the control arm is consisted of patients with treatment as usual (TAU), i. e. waitlist condition who will receive standard antidepressant medication with or without psychotherapies. Patients in TAU arm will be offered one free course (total 10 sessions) of acupuncture treatment in TCM outpatient clinic after they have been discharged from the ward. All patients' depressive symptoms, cognitive function, quality of life and functioning will be assessed and compared at pre-treatment (baseline), immediately after in-hospital acupuncture treatment, one-month post-treatment and 3-month post-treatment. In addition, we will analyze the association of sociodemographic and clinical characteristics with the treatment effect of acupuncture.
This study will be the first study to examine whether acupuncture is a viable augmentation treatment for in-hospital patients with depression. Expected outcomes will include determining the relative short and medium-term clinical effects from the most commonly used acupuncture treatment modalities in a local and multiethnic population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized single blinded controlled trial
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: Acupuncture |
| Treatment as usual | Active comparator | Other: Treatment as usual |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥21 years.
- DSM-V diagnosis of current Major Depressive Episode.
- Montgomery-Asberg Depression Rating Scale score of 20 or more.
- Able to give informed consent.
Key exclusion criteria (7 listed)
- History of psychosis or mania
- With current ECT or neurostimulation treatment.
- With severe heart or renal condition
- Currently taking blood thinning drug including Aspirin etc.
- Endocrine abnormalities (e.g., hypothyroidism, unstable diabetes);
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 |
|---|---|---|
| AcupunctureUnilateral and bilateral acupuncture points: Du 20 and GV 29,39 MS1, MS2, MS3 and MS4,40 Location of points: Number of needles: 9 Depth of insertion: MS1, MS2, MS3: insert the needle obliquely in the frontal direction for 1 cm Du 20: insert the needle obliquely in the frontal direction for 0.5 cm GV 29: insert the needle obliquely and downward for 0.5 cm Needles retained for 20 min Needle type: Han Yi 0.25x25 mm Treatment regimen: once per day for 2 weeks | Device | Acupuncture |
| Treatment as usualInpatient psychiatric care for depression | Other | Treatment as usual |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
Time frame: 2 week post treatment
MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorder (scored 0 to 60 with higher scores meaning worse outcome)
Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
Time frame: 1 month post treatment
MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.(scored 0 to 60 with higher scores meaning worse outcome)
Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
Time frame: 3 months post treatment
MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.(scored 0 to 60 with higher scores meaning worse outcome)
5 secondary outcomes
Montreal Cognitive Assessment (MoCA) (clinician administered).
Time frame: 2 weeks, 1 month, 3 months post treatment
EQ-5D (self-administered)
Time frame: 2 weeks, 1 month, 3 months post treatment
Quick Inventory of Depressive Symptomatology- Self report 16 items (QIDS-SR16) (subjective, self-administered)
Time frame: 2 weeks, 1 month, 3 months post treatment
Global Assessment of Functioning (GAF) (clinician administered)
Time frame: 2 weeks, 1 month, 3 months post treatment
TCM Assessment Form (Depression)
Time frame: 2 weeks, 1 month, 3 months post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Phern Chern Tor, MBBS principal investigator
Institute of Mental Health, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Treatment as usual in people with Depression, run by Institute of Mental Health, Singapore at 1 site in Singapore.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phern Chern Tor, MBBS (63892000, phern_chern_tor@imh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered). (time frame: 2 week post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2022.