Acupuncture Augmentation for Inpatients With Major Depression Disorder

NCT05452746 | Unknown

• 1 other identifier: IMHSingapore
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Acupuncture

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  3 months post treatment

Secondary Outcomes (5)

• Montreal Cognitive Assessment (MoCA) (clinician administered).

  2 weeks, 1 month, 3 months post treatment

• EQ-5D (self-administered)

  2 weeks, 1 month, 3 months post treatment

• Quick Inventory of Depressive Symptomatology- Self report 16 items (QIDS-SR16) (subjective, self-administered)

  2 weeks, 1 month, 3 months post treatment

• Global Assessment of Functioning (GAF) (clinician administered)

  2 weeks, 1 month, 3 months post treatment

• TCM Assessment Form (Depression)

  2 weeks, 1 month, 3 months post treatment

Study Arms (2)

Acupuncture

EXPERIMENTAL

Device: Acupuncture

Treatment as usual

ACTIVE COMPARATOR

Other: Treatment as usual

Interventions

Acupuncture DEVICE

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

Acupuncture

Treatment as usual OTHER

Inpatient psychiatric care for depression

Treatment as usual

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Mental Health, Singapore: lead
• Nanyang Technological University: collaborator

Study Sites (1)

Institute of Mental Health

Singapore, 539747, Singapore

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Acupuncture Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies

Study Officials

• Phern Chern Tor, MBBS

  Institute of Mental Health, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phern Chern Tor, MBBS

CONTACT

63892000; phern_chern_tor@imh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor blinded to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized single blinded controlled trial

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 11, 2022
• Study Start: June 24, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)