Clinical trial NCT05452746: Acupuncture Augmentation for Inpatients With Major Depression Disorder
Official title: Acupuncture Augmentation Therapy for In-hospital Patients With Major Depression Disorder: a Pragmatic, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Acupuncture
Lead sponsor: Institute of Mental Health, Singapore
Sponsor class: OTHER
Collaborators: name: Nanyang Technological University
First posted: 2022-07-11
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized single blinded controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥21 years.
2. DSM-V diagnosis of current Major Depressive Episode.
3. Montgomery-Asberg Depression Rating Scale score of 20 or more.
4. Able to give informed consent.

Exclusion Criteria:

1. History of psychosis or mania
2. With current ECT or neurostimulation treatment.
3. With severe heart or renal condition
4. Currently taking blood thinning drug including Aspirin etc.
5. Endocrine abnormalities (e.g., hypothyroidism, unstable diabetes);
6. History of central nervous system involvement (e.g., seizures, brain injury, neurologic ill- ness);
7. Pregnancy.

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
timeFrame: 2 week post treatment
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
timeFrame: 1 month post treatment
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
timeFrame: 3 months post treatment
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA) (clinician administered).
timeFrame: 2 weeks, 1 month, 3 months post treatment
measure: EQ-5D (self-administered)
timeFrame: 2 weeks, 1 month, 3 months post treatment
measure: Quick Inventory of Depressive Symptomatology- Self report 16 items (QIDS-SR16) (subjective, self-administered)
timeFrame: 2 weeks, 1 month, 3 months post treatment
measure: Global Assessment of Functioning (GAF) (clinician administered)
timeFrame: 2 weeks, 1 month, 3 months post treatment
measure: TCM Assessment Form (Depression)
timeFrame: 2 weeks, 1 month, 3 months post treatment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Institute of Mental Health
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Phern Chern Tor, MBBS
role: PRINCIPAL_INVESTIGATOR
References: