NCT05452746

Acupuncture Augmentation for Inpatients With Major Depression Disorder

Status unknown NA Last updated 11 July 2022

What this trial tests

NA trial testing Acupuncture in Depression in 84 participants. Status unknown.

Timeline

24 June 2022

Primary endpoint
31 May 2025

31 May 2025

Quick facts

Lead sponsor	Institute of Mental Health, Singapore
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	84
Start date	24 June 2022
Primary completion	31 May 2025
Estimated completion	31 May 2025
Sites	1 location across Singapore

Drugs / interventions tested

• Acupuncture — full drug profile →
• Treatment as usual

Conditions studied

• Depression — all drugs for Depression →

Sponsor

Institute of Mental Health, Singapore

Who can join

21 and older, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.