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Homeopathic Treatment for Depression in Peri- and Postmenopausal Women (HOMDEP-MENOP)

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ClinicalTrials.gov Identifier: NCT01635218
Recruitment Status : Completed
First Posted : July 9, 2012
Results First Posted : September 23, 2014
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Emma del Carmen Macías-Cortés, MD, PhD, Hospital Juarez de Mexico

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Moderate Depression
Menopausal and Postmenopausal Disorders
Interventions Drug: Individualized homeopathic treatment
Drug: Fluoxetine
Drug: Placebo
Enrollment 133
Recruitment Details The study was conducted in a public, academic and research hospital in Mexico City. Participants were recruited since March 2012 until December 2013. The recruitment methods included advertisements through internet, community groups,liaisons with health professionals, posters and brochures distributed among hospital population.
Pre-assignment Details Five hundred thirty-four women seeking medical care for menopausal complaints were interviewed and screened. Four hundred and one women did not meet inclusion criteria and were excluded: no depression (44), mild depression (150), severe depression and/or attempt of suicide (43), did not meet other inclusion criteria (164).
Arm/Group Title Individualized Homeopathic Treatment Fluoxetine Placebo
Hide Arm/Group Description

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

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.

Selective serotonin reuptake inhibitor.

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.

Fluoxetine placebo plus individualized homeopathic placebo

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.

Period Title: Overall Study
Started 44 46 43
Completed 41 39 37
Not Completed 3 7 6
Reason Not Completed
Lost to Follow-up             3             7             6
Arm/Group Title Individualized Homeopathic Treatment Fluoxetine Placebo Total
Hide Arm/Group Description

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

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.

Selective serotonin reuptake inhibitor.

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.

Fluoxetine placebo plus individualized homeopathic placebo

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.

Total of all reporting groups
Overall Number of Baseline Participants 44 46 43 133
Hide Baseline Analysis Population Description
All patientes under randomization were included in the primary efficacy population (intention-to-treat population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 46 participants 43 participants 133 participants
49  (6.4) 49.2  (5.3) 48.8  (5.8) 49  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 46 participants 43 participants 133 participants
Female
44
 100.0%
46
 100.0%
43
 100.0%
133
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 46 participants 43 participants 133 participants
Hispanic or Latino
44
 100.0%
46
 100.0%
43
 100.0%
133
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 44 participants 46 participants 43 participants 133 participants
44 46 43 133
Baseline score in 17-item Hamilton Rating Scale for Depression   [1] 
Mean (Standard Deviation)
Unit of measure:  Units in Hamilton Scale
Number Analyzed 44 participants 46 participants 43 participants 133 participants
21.2  (2.7) 20.6  (2.9) 20.7  (3.1) 20.8  (2.9)
[1]
Measure Description:

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). The score of the 17 items was summed.

The score presented here is the baseline score of Hamilton Scale, the final score after the 6 weeks treatment is presented in Outcomes measure data table.

Baseline score in Beck Depression Inventory   [1] 
Mean (Standard Deviation)
Unit of measure:  Units in Beck Depression Inventory
Number Analyzed 44 participants 46 participants 43 participants 133 participants
26.3  (7.2) 25.0  (7.8) 27.0  (9.0) 26.1  (8.0)
[1]
Measure Description:

Beck Depression Inventory is a 21-question multiple-choice self-report inventory. For this study a total score range was assessed: 0 (without depression) up to 63 (most severe depression): 0 - 8 is considered normal, 9 - 18 (mild to moderate depression), 19 - 28 (moderate to severe depression), > 29 (severe depression). The score of the 21 questions was summed.

The score presented here is the baseline score of BDI, the final score after the 6 weeks treatment is presented in the Outcome measure data table.

Baseline score in Greene Climacteric Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units in Greene Climacteric Scale
Number Analyzed 44 participants 46 participants 43 participants 133 participants
35.3  (8.5) 33.5  (10.1) 37.9  (11.5) 35.5  (10.2)
[1]
Measure Description:

Greene Climacteric Scale is intended to be a standard measure of core climacteric symptoms. For this study a total range was assessed: 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). 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).

The score presented here is the baseline score of Greene Climacteric Scale before treatment.

1.Primary Outcome
Title Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.
Hide Description 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).
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients under randomization were included in the primary efficacy population (intention-to-treat population), regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented in outcome measure data table are the final scores in Hamilton Scale after 6 weeks of treatment.
Arm/Group Title Individualized Homeopathic Treatment Fluoxetine Placebo
Hide Arm/Group Description:

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

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.

Selective serotonin reuptake inhibitor.

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.

Fluoxetine placebo plus individualized homeopathic placebo

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.

Overall Number of Participants Analyzed 44 46 43
Mean (Standard Deviation)
Unit of Measure: Units in Hamilton Scale
9.9  (3) 11.7  (3.7) 15  (3.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Homeopathic Treatment, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The ANOVA result (p<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.0
Confidence Interval (2-Sided) 95%
3.1 to 7.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The ANOVA result (p<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
1.31 to 5.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.81
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Beck Depression Inventory at 6 Weeks.
Hide Description 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).
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets. The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.
Arm/Group Title Individualized Homeopathic Treatment Fluoxetine Placebo
Hide Arm/Group Description:

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

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.

Selective serotonin reuptake inhibitor.

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.

Fluoxetine placebo plus individualized homeopathic placebo

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.

Overall Number of Participants Analyzed 44 46 43
Mean (Standard Deviation)
Unit of Measure: Units in Beck Depression Inventory
12  (6.1) 14.2  (7.8) 15.5  (8.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Homeopathic Treatment, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments The statistical significant ANOVA result (p<0.05) suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
-0.73 to 7.61
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.71
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments The ANOVA result (p<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
-2.93 to 5.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.73
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Responder Rates at 6 Weeks.
Hide Description 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.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.
Arm/Group Title Individualized Homeopathic Treatment Fluoxetine Placebo
Hide Arm/Group Description:

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

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.

Selective serotonin reuptake inhibitor.

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.

Fluoxetine placebo plus individualized homeopathic placebo

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.

Overall Number of Participants Analyzed 44 46 43
Measure Type: Number
Unit of Measure: participants with a decrease >50% in HS
24 19 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Homeopathic Treatment, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
0.03 to 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
0.06 to 0.56
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Greene´s Scale at 6 Weeks.
Hide Description 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).
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.
Arm/Group Title Individualized Homeopathic Treatment Fluoxetine Placebo
Hide Arm/Group Description:

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

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.

Selective serotonin reuptake inhibitor.

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.

Fluoxetine placebo plus individualized homeopathic placebo

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.

Overall Number of Participants Analyzed 44 46 43
Mean (Standard Deviation)
Unit of Measure: Units in Green Scale
18.1  (7.8) 23.1  (12.3) 26.8  (11.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Homeopathic Treatment, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The ANOVA result (p<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.6
Confidence Interval (2-Sided) 95%
2.72 to 14.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.424
Comments The ANOVA result (p<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
-2.33 to 9.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.37
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Remission Rates at 6 Weeks
Hide Description 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.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.
Arm/Group Title Individualized Homeopathic Treatment Fluoxetine Placebo
Hide Arm/Group Description:

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

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.

Selective serotonin reuptake inhibitor.

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.

Fluoxetine placebo plus individualized homeopathic placebo

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.

Overall Number of Participants Analyzed 44 46 43
Measure Type: Number
Unit of Measure: participants with a score of < 7 in HS
7 7 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Homeopathic Treatment, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.26
Confidence Interval 95%
0.05 to 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
0.05 to 1.39
Estimation Comments [Not Specified]
Time Frame During study duration and 2 weeks after the final dose (8 weeks).
Adverse Event Reporting Description Daily patient's questionnaire and medical examination at each follow-up.
 
Arm/Group Title Individualized Homeopathic Treatment Fluoxetine Placebo
Hide Arm/Group Description

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

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.

Selective serotonin reuptake inhibitor.

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 could be repeated at week 4.

Fluoxetine placebo plus individualized homeopathic placebo

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.

All-Cause Mortality
Individualized Homeopathic Treatment Fluoxetine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Individualized Homeopathic Treatment Fluoxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/44 (0.00%)      0/46 (0.00%)      0/43 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Individualized Homeopathic Treatment Fluoxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/44 (43.18%)      24/46 (52.17%)      16/43 (37.21%)    
Gastrointestinal disorders       
Dyspepsia   6/44 (13.64%)  6 1/46 (2.17%)  1 6/43 (13.95%)  6
Nausea   5/44 (11.36%)  5 2/46 (4.35%)  2 2/43 (4.65%)  2
Constipation   2/44 (4.55%)  2 4/46 (8.70%)  4 6/43 (13.95%)  6
Diarrhea   3/44 (6.82%)  3 3/46 (6.52%)  3 3/43 (6.98%)  3
General disorders       
Dizziness   4/44 (9.09%)  4 5/46 (10.87%)  5 4/43 (9.30%)  4
Fatigue   5/44 (11.36%)  5 4/46 (8.70%)  4 6/43 (13.95%)  6
Nervous system disorders       
Headache   3/44 (6.82%)  3 6/46 (13.04%)  6 5/43 (11.63%)  5
Psychiatric disorders       
Insomnia   6/44 (13.64%)  6 5/46 (10.87%)  5 6/43 (13.95%)  6
Anxiety   4/44 (9.09%)  4 8/46 (17.39%)  8 2/43 (4.65%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Emma del Carmen Macías-Cortés
Organization: Hospital Juárez de México
Phone: +52 55 5747 7605
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emma del Carmen Macías-Cortés, MD, PhD, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier: NCT01635218     History of Changes
Other Study ID Numbers: HJM2030/12-A
First Submitted: June 30, 2012
First Posted: July 9, 2012
Results First Submitted: September 8, 2014
Results First Posted: September 23, 2014
Last Update Posted: October 9, 2014