Homeopathy for Major Depressive Disorder: protocol for N-of-1 studies (HOMDD-1 Studies)

Authors

  • Ubiratan Adler Faculdade de Medicina de Jundiaí, São Paulo/Brazil
  • Maristela Schiabel Adler Department of Medicine/Federal University of São Carlos, São Carlos (São Paulo), Brazil.
  • Amarilys de Toledo Cesar HN-Cristiano Institute, São Paulo (São Paulo), Brazil.
  • Helen de Freitas Santos Federal Institute of Education, Science and Technology of São Paulo, Birigui (Sao Paulo), Brazil
  • Patrícia Andréa da Fonseca Magalhães Research Management Unit, Ceará Federal University Hospital Complex/Brazilian Company of Hospital Services, Fortaleza (Ceará), Brazil.
  • Renan dos Santos Nogueira Medical Residency Program, Walter Cantídio University Hospital/Federal University of Ceará, Fortaleza (Ceará), Brazil
  • Eugênio de Moura Campos Department of Clinical Medicine, Faculty of Medicine/Federal University of Ceará, Fortaleza (Ceará), Brazil.
  • Antonio Brazil Viana Júnior Research Management Unit, Ceará Federal University Hospital Complex/Brazilian Company of Hospital Services, Fortaleza (Ceará), Brazil.
  • Lia Lira Olivier Sanders Department of Clinical Medicine, Faculty of Medicine/Federal University of Ceará, Fortaleza (Ceará), Brazil.

DOI:

https://doi.org/10.51910/ijhdr.v22i2.1316

Keywords:

Homeopathy; Depression; N-of-1 studies

Abstract

BACKGROUND. Using the N-of-1 methodology, we will investigate the effectiveness and safety of a standardized homeopathy protocol in treating ten individual cases of major depression. PATIENTS. Women and men at age over 18 years with a diagnosis of a Major Depressive Episode given by a psychiatrist, who have presented a therapeutic response (reduction ≥ 50% of the baseline depression score, kept for at least four weeks) during a prior open homeopathic treatment following the protocol of the sixth edition of the Organon, with or without concomitant use of psychotropic drugs. METHODS. Interventions: individualized homeopathy following the same protocol, administered in a solution containing a globule of the fifty-millesimal potency diluted in 20 ml of 30% alcohol; placebo - a hydroalcoholic solution containing 20 ml of 30% alcohol, in the same posology as the individualized homeopathic medicine. Crossover study: the participant will go through three consecutive treatment blocks, with two random and masked treatment periods (A or B) each, corresponding to homeopathy or placebo. Treatment periods will have two, four, and eight weeks in the first, second, and third blocks, respectively. A clinically significant worsening (characterized by an augmentation in BDI inclusion score ≥ 30%) will result in the termination of participation in the study and resumption of the open treatment. Primary measure: behavior of the score of the Beck-II Depression Inventory (BDI-II), self-evaluated by participants at weeks 0-2-4-8-12-16-20-24-28 and analyzed throughout the study concerning homeopathy and placebo partitions. Secondary measures: score of the Clinical Global Impression Scale; mental and physical health scores assessed by the 12-Item Short-Form Health Survey; participant's blind preference for treatment A or B at each block; clinical worsening and Adverse Events. The participant, assistant physician, evaluator, and statistician will remain blinded for the study treatments until the completion of data analysis from every participant.

Author Biography

Ubiratan Adler, Faculdade de Medicina de Jundiaí, São Paulo/Brazil

Faculdade de Medicina de Jundiaí, Sao Paulo/Brazil

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Published

2023-12-20

How to Cite

Adler, U., Schiabel Adler, M., de Toledo Cesar, A., de Freitas Santos, H., Andréa da Fonseca Magalhães, P., dos Santos Nogueira , R., de Moura Campos, E., Brazil Viana Júnior, A., & Lira Olivier Sanders , L. (2023). Homeopathy for Major Depressive Disorder: protocol for N-of-1 studies (HOMDD-1 Studies). International Journal of High Dilution Research - ISSN 1982-6206, 22(2), 52–52. https://doi.org/10.51910/ijhdr.v22i2.1316