Homeopathic Treatment for Depression in Peri- and Postmenopausal Women

Moderate Depression Clinical Trial

— HOMDEP-MENOP  

Official title:

Efficacy of Individualized Homeopathic Treatment for Moderate to Severe Depression in Peri- and Postmenopausal Women: a Randomized Placebo-controlled, Double-blind, Double-dummy, Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635218
• Other study ID #: HJM2030/12-A
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2012
• Last updated: September 30, 2014
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: Hospital Juarez de Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

Description:

Perimenopausal period is characterized by an increased risk of depressive symptoms. Major depression is one of the most disabling medical conditions worldwide. At present, it is becoming more difficult to prove that antidepressants actually work better than placebo in clinical trials.Use of homeopathy to treat depression is widespread, but there is a lack of clinical trails about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression in general population. The purpose of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate depression in peri- and postmenopausal women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Menopausal and Postmenopausal Disorders
• Moderate Depression

Intervention

Drug:
• Individualized homeopathic treatment
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.
• Fluoxetine
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.
• Placebo
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.

Locations

Country	Name	City	State
Mexico	Hospital Juárez de México	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Juarez de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (26)

Adler UC, Krüger S, Teut M, Lüdtke R, Bartsch I, Schützler L, Melcher F, Willich SN, Linde K, Witt CM. Homeopathy for depression--DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study. Trials. 2011 Feb 14;12:43. doi: 10.1186/1745-6215-12-43. — View Citation

Adler UC, Paiva NM, Cesar AT, Adler MS, Molina A, Padula AE, Calil HM. Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial. Evid Based Complement Alternat Med. 2011;2011:520182. doi: 10.1093/ecam/nep114. Epub 2011 Jun 8. — View Citation

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Dean ME, Coulter MK, Fisher P, Jobst K, Walach H; Delphi Panel of the CONSORT Group. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT*. Forsch Komplementmed. 2006 Dec;13(6):368-71. Epub 2006 Dec 21. — View Citation

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Lüdtke R, Rutten AL. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. J Clin Epidemiol. 2008 Dec;61(12):1197-204. doi: 10.1016/j.jclinepi.2008.06.015. Epub 2008 Oct 1. Review. — View Citation

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Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010 Mar 24;7(3):e1000251. doi: 10.1371/journal.pmed.1000251. — View Citation

Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig 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. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Beck Depression Inventory at 6 Weeks.	Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory that assess severity of depression. A total score range was assessed at baseline and after six weeks of treatment. A score 0 (without depression) up to 63 (most severe depression). For this study the change was calculated as the later time point (total score in BDI at 6 weeks) minus the earlier time point (total score in BDI at baseline). A score 0 - 8 is considered normal, 9 - 18 (mild to moderate depression), 19 - 28 (moderate to severe depression), > 29 (severe depression).	Baseline and 6 weeks	No
Secondary	Responder Rates at 6 Weeks.	17-item Hamilton Rating Scale for Depression 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 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Responder rate definition: a decrease of 50% or more from baseline score using 17-item Hamilton Rating Scale for Depression after six weeks treatment.	6 weeks	No
Secondary	Change From Baseline in Greene´s Scale at 6 Weeks.	Greene Climacteric Scale (GS) is intended to be a standard measure of core climacteric symptoms. For this study a total range was assessed at baseline and after six weeks of treatment. A total score 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). The change was calculated as the later time point (total score in GS at 6 weeks) minus the earlier time point (total score at baseline).The scale measures four separate sub-scales (anxiety, depression, somatic symptoms and sexual function). The score of the four sub-scales was summed. A total score of 0 -10 is considered without symptoms, 11 - 29 (mild symptoms), 30 - 49 (moderate symptoms) and > 50 (severe symptoms).	Baseline and 6 weeks	No
Secondary	Remission Rates at 6 Weeks	17-item Hamilton Rating Scale for Depression 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 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Remission rate definition: 17-item Hamilton Rating Scale for Depression score < 7 points after 6 weeks of treatment.	6 weeks	No