- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01635218
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women (HOMDEP-MENOP)
September 30, 2014 updated by: Emma del Carmen Macías-Cortés, MD, PhD, Hospital Juarez de Mexico
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
133
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mexico City, Mexico, 07760
- Hospital Juarez de Mexico
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Individualized homeopathic treatment
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
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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.
Other Names:
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EXPERIMENTAL: Fluoxetine
Selective serotonin reuptake inhibitor.
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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.
Other Names:
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PLACEBO_COMPARATOR: Placebo
Fluoxetine placebo plus individualized homeopathic placebo
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.
Time Frame: Baseline and 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).
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Baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Beck Depression Inventory at 6 Weeks.
Time Frame: Baseline and 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).
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Baseline and 6 weeks
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Responder Rates at 6 Weeks.
Time Frame: 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.
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6 weeks
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Change From Baseline in Greene´s Scale at 6 Weeks.
Time Frame: Baseline and 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).
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Baseline and 6 weeks
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Remission Rates at 6 Weeks
Time Frame: 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.
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6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emma del Carmen Macías-Cortés, MD, PhD, Hospital Juarez de Mexico
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
- Murray CJ, Lopez AD. Evidence-based health policy--lessons from the Global Burden of Disease Study. Science. 1996 Nov 1;274(5288):740-3. doi: 10.1126/science.274.5288.740. No abstract available.
- 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.
- Frank E, Prien RF, Jarrett RB, Keller MB, Kupfer DJ, Lavori PW, Rush AJ, Weissman MM. Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence. Arch Gen Psychiatry. 1991 Sep;48(9):851-5. doi: 10.1001/archpsyc.1991.01810330075011.
- Hale GE, Zhao X, Hughes CL, Burger HG, Robertson DM, Fraser IS. Endocrine features of menstrual cycles in middle and late reproductive age and the menopausal transition classified according to the Staging of Reproductive Aging Workshop (STRAW) staging system. J Clin Endocrinol Metab. 2007 Aug;92(8):3060-7. doi: 10.1210/jc.2007-0066. Epub 2007 Jun 5.
- Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008 Feb;5(2):e45. doi: 10.1371/journal.pmed.0050045.
- Greenberg PE, Stiglin LE, Finkelstein SN, Berndt ER. The economic burden of depression in 1990. J Clin Psychiatry. 1993 Nov;54(11):405-18.
- Williams LM, Rush AJ, Koslow SH, Wisniewski SR, Cooper NJ, Nemeroff CB, Schatzberg AF, Gordon E. International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol. Trials. 2011 Jan 5;12:4. doi: 10.1186/1745-6215-12-4.
- Simon GE, VonKorff M, Barlow W. Health care costs of primary care patients with recognized depression. Arch Gen Psychiatry. 1995 Oct;52(10):850-6. doi: 10.1001/archpsyc.1995.03950220060012.
- Cohen LS, Soares CN, Vitonis AF, Otto MW, Harlow BL. Risk for new onset of depression during the menopausal transition: the Harvard study of moods and cycles. Arch Gen Psychiatry. 2006 Apr;63(4):385-90. doi: 10.1001/archpsyc.63.4.385.
- Freeman EW, Sammel MD, Lin H, Nelson DB. Associations of hormones and menopausal status with depressed mood in women with no history of depression. Arch Gen Psychiatry. 2006 Apr;63(4):375-82. doi: 10.1001/archpsyc.63.4.375.
- Freeman EW, Sammel MD, Liu L, Gracia CR, Nelson DB, Hollander L. Hormones and menopausal status as predictors of depression in women in transition to menopause. Arch Gen Psychiatry. 2004 Jan;61(1):62-70. doi: 10.1001/archpsyc.61.1.62.
- Rapkin AJ. Vasomotor symptoms in menopause: physiologic condition and central nervous system approaches to treatment. Am J Obstet Gynecol. 2007 Feb;196(2):97-106. doi: 10.1016/j.ajog.2006.05.056.
- Fava M, Davidson KG. Definition and epidemiology of treatment-resistant depression. Psychiatr Clin North Am. 1996 Jun;19(2):179-200. doi: 10.1016/s0193-953x(05)70283-5.
- Davidson JR, Crawford C, Ives JA, Jonas WB. Homeopathic treatments in psychiatry: a systematic review of randomized placebo-controlled studies. J Clin Psychiatry. 2011 Jun;72(6):795-805. doi: 10.4088/JCP.10r06580.
- Adler UC, Kruger S, Teut M, Ludtke R, Bartsch I, Schutzler 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.
- Freeman MP, Mischoulon D, Tedeschini E, Goodness T, Cohen LS, Fava M, Papakostas GI. Complementary and alternative medicine for major depressive disorder: a meta-analysis of patient characteristics, placebo-response rates, and treatment outcomes relative to standard antidepressants. J Clin Psychiatry. 2010 Jun;71(6):682-8. doi: 10.4088/JCP.10r05976blu.
- Linde K, Melchart D. Randomized controlled trials of individualized homeopathy: a state-of-the-art review. J Altern Complement Med. 1998 Winter;4(4):371-88. doi: 10.1089/acm.1998.4.371.
- Thompson TD, Weiss M. Homeopathy--what are the active ingredients? An exploratory study using the UK Medical Research Council's framework for the evaluation of complex interventions. BMC Complement Altern Med. 2006 Nov 13;6:37. doi: 10.1186/1472-6882-6-37.
- 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. doi: 10.1159/000097073. Epub 2006 Dec 21.
- 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.
- 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.
- 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.
- 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.
- Mulrow CD, Williams JW Jr, Chiquette E, Aguilar C, Hitchcock-Noel P, Lee S, Cornell J, Stamm K. Efficacy of newer medications for treating depression in primary care patients. Am J Med. 2000 Jan;108(1):54-64. doi: 10.1016/s0002-9343(99)00316-2.
- Dawson MY, Michalak EE, Waraich P, Anderson JE, Lam RW. Is remission of depressive symptoms in primary care a realistic goal? A meta-analysis. BMC Fam Pract. 2004 Sep 7;5:19. doi: 10.1186/1471-2296-5-19.
- 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.
- 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.
- 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. Erratum In: PLoS One. 2015;10(5):e0127719.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (ACTUAL)
February 1, 2014
Study Completion (ACTUAL)
March 1, 2014
Study Registration Dates
First Submitted
June 30, 2012
First Submitted That Met QC Criteria
July 3, 2012
First Posted (ESTIMATE)
July 9, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
October 9, 2014
Last Update Submitted That Met QC Criteria
September 30, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- HJM2030/12-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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