title: Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  The perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depressive symptoms. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression. In classical homeopathy, an individually selected homeopathic remedy is prescribed after a complete case history of the patient. The aim of this study is to assess the efficacy and safety of the homeopathic individualized treatment versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression.
  
  
  METHODS
  A randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a six-week follow-up study was designed. The study will be conducted in a public research hospital in Mexico City (Juárez de México Hospital) in the outpatient service of homeopathy. One hundred eighty nine peri- and postmenopausal women diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (moderate to severe intensity) will be included. The primary outcome is change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression after the fourth and sixth week of treatment. Secondary outcomes are: Beck Depression Inventory change in mean score, Greene's Scale change in mean score, response and remission rates and safety. Efficacy data will be analyzed in the intention-to-treat population. To determine differences in the primary and secondary outcomes among groups at baseline and weeks four and six, data will be analyzed by analysis of variance for independent measures with the Bonferroni post-hoc test.
  
  
  CONCLUSIONS
  This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic individualized treatment using C-potencies versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. It is an attempt to deal with the obstacles of homeopathic research due to the need for individual prescriptions in one of the most common psychiatric diseases.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01635218.
authors.affiliation: Escuela Superior de Medicina, Instituto Politécnico Nacional, Ave, Plan de San Luis y Salvador Díaz Mirón, Casco de Santo Tomás, Distrito Federal CP 11340, Mexico. ecmc2008@hotmail.es
authors.forename: Emma del Carmen
authors.initials: Edel C
authors.lastname: Macías-Cortés
authors.forename: Leopoldo
authors.initials: L
authors.lastname: Aguilar-Faisal
authors.forename: Juan
authors.initials: J
authors.lastname: Asbun-Bojalil
mesh_terms: D000704:Analysis of Variance; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D003863:Depression / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D006779:Hospitals, Public; D006801:Humans; D008419:Materia Medica / Q000009:adverse effects / Q000627:therapeutic use*; D008800:Mexico; D047648:Perimenopause / Q000523:psychology*; D017698:Postmenopause / Q000523:psychology*; D057285:Precision Medicine; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018687:Antidepressive Agents, Second-Generation; D005473:Fluoxetine; D008419:Materia Medica; D017367:Selective Serotonin Reuptake Inhibitors