Acupuncture Augmentation for Inpatients With Major Depression Disorder

  • STATUS
    Recruiting
  • End date
    May 31, 2025
  • participants needed
    84
  • sponsor
    Institute of Mental Health, Singapore
Updated on 4 October 2022
depressed mood
depressive episode

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.

Details
Condition Depression
Treatment Acupuncture, Treatment As Usual
Clinical Study IdentifierNCT05452746
SponsorInstitute of Mental Health, Singapore
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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