Homeopathic Treatment for Depression in Peri- and Postmenopausal Women

NCT01635218 | Completed Phase 2 Results DMC

• 1 other identifier: HJM2030/12-A
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate to severe depression in peri- and postmenopausal women.

Conditions

Moderate Depression; Menopausal and Postmenopausal Disorders

Keywords

Depression; Perimenopause; Postmenopause; Homeopathy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.

  17-item Hamilton Rating Scale for Depression (HRSD) is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in HRSD was assessed at baseline and after six weeks of treatment. For this study the change was calculated as the later time point (total score in 17- HRSD at 6 weeks) minus the earlier time point (total score at baseline). A score \< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \> 24 (severe depression).

  Baseline and 6 weeks

Secondary Outcomes (4)

• Change From Baseline in Beck Depression Inventory at 6 Weeks.

  Baseline and 6 weeks

• Responder Rates at 6 Weeks.

  6 weeks

• Change From Baseline in Greene´s Scale at 6 Weeks.

  Baseline and 6 weeks

• Remission Rates at 6 Weeks

  6 weeks

Study Arms (3)

Individualized homeopathic treatment

EXPERIMENTAL

Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.

Drug: Individualized homeopathic treatment

Fluoxetine

EXPERIMENTAL

Selective serotonin reuptake inhibitor.

Drug: Fluoxetine

Placebo

PLACEBO COMPARATOR

Fluoxetine placebo plus individualized homeopathic placebo

Drug: Placebo

Interventions

Individualized homeopathic treatment DRUG

A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.

Also known as: Homeopathic remedies, Homeopathic medicines

Individualized homeopathic treatment

Fluoxetine DRUG

20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.

Also known as: Prozac

Fluoxetine

Placebo DRUG

Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.

Also known as: Fluoxetine placebo, Individualized homeopathic placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major depression according to DSM-IV
• Moderate to severe depression according to 17-item Hamilton Rating Scale for Depression (14-24 score)
• No current use of homeopathic treatment for depression or antidepressants or anxiolytic drugs 3 months prior to study entry
• Not be currently taking psychotherapy for at least 3 months before study entry
• Early transition to menopause defined by a change in cycle length of 7 days or longer in either direction from the participant´s own baseline for at least 2 cycles
• Late transition to menopause defined as 3 to 11 months of amenorrhea
• Postmenopausal stage defined by 12 months or more of amenorrhea
• Capability and willingness to give informed consent and to comply with the study procedures

You may not qualify if:

• Pregnancy or breastfeeding
• Other psychiatric disorders different from moderate to severe depression (severe depression, schizophrenia, psychotic disorders, bipolar affective disorders, suicide attempt)
• Alcohol or other substance abuse
• Known allergy to fluoxetine
• Cancer or hepatic diseases

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

Study Sites (1)

Hospital Juárez de México

Mexico City, Mexico City, 07760, Mexico

Location

Related Publications (30)

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• Ludtke R, Rutten ALB. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. J Clin Epidemiol. 2008 Dec;61(12):1197-1204. doi: 10.1016/j.jclinepi.2008.06.015. Epub 2008 Oct 1.

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• Bordet MF, Colas A, Marijnen P, Masson J, Trichard M. Treating hot flushes in menopausal women with homeopathic treatment--results of an observational study. Homeopathy. 2008 Jan;97(1):10-5. doi: 10.1016/j.homp.2007.11.005.

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• Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JA, Pewsner D, Egger M. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet. 2005 Aug 27-Sep 2;366(9487):726-32. doi: 10.1016/S0140-6736(05)67177-2.

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• Macias-Cortes EDC, Llanes-Gonzalez L, Aguilar-Faisal L, Asbun-Bojalil J. Response to Individualized Homeopathic Treatment for Depression in Climacteric Women with History of Domestic Violence, Marital Dissatisfaction or Sexual Abuse: Results from the HOMDEP-MENOP Study. Homeopathy. 2018 Aug;107(3):202-208. doi: 10.1055/s-0038-1654709. Epub 2018 Jun 5.

  PMID: 29871025 DERIVED

• Macias-Cortes ED, Llanes-Gonzalez L, Aguilar-Faisal L, Asbun-Bojalil J. Is metabolic dysregulation associated with antidepressant response in depressed women in climacteric treated with individualized homeopathic medicines or fluoxetine? The HOMDEP-MENOP Study. Homeopathy. 2017 Feb;106(1):3-10. doi: 10.1016/j.homp.2016.11.002. Epub 2017 Jan 10.

  PMID: 28325221 DERIVED

• Macias-Cortes Edel C, Llanes-Gonzalez L, Aguilar-Faisal L, Asbun-Bojalil J. Individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP study): a randomized, double-dummy, double-blind, placebo-controlled trial. PLoS One. 2015 Mar 13;10(3):e0118440. doi: 10.1371/journal.pone.0118440. eCollection 2015.

  PMID: 25768800 DERIVED

• Macias-Cortes Edel C, Aguilar-Faisal L, Asbun-Bojalil J. 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. Trials. 2013 Apr 23;14:105. doi: 10.1186/1745-6215-14-105.

  PMID: 23782520 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Materia Medica; Homeopathy; Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Complementary Therapies; Therapeutics; Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Dr. Emma del Carmen Macías-Cortés
• Organization: Hospital Juárez de México

ecmc2008@hotmail.es

+52 55 5747 7605

Study Officials

• Emma del Carmen Macías-Cortés, MD, PhD

  Hospital Juárez de México

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 30, 2012
• First Posted: July 9, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 9, 2014
• Results First Posted: September 23, 2014

Record last verified: 2014-09

Locations

ME (1)