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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01635218
First Posted: July 9, 2012
Last Update Posted: October 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Emma del Carmen Macías-Cortés, MD, PhD, Hospital Juarez de Mexico
Results First Submitted: September 8, 2014  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Individualized Homeopathic Treatment

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.

Fluoxetine

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.

Placebo

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.


Participant Flow:   Overall Study
    Individualized Homeopathic Treatment   Fluoxetine   Placebo
STARTED   44   46   43 
COMPLETED   41   39   37 
NOT COMPLETED   3   7   6 
Lost to Follow-up                3                7                6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patientes under randomization were included in the primary efficacy population (intention-to-treat population).

Reporting Groups
  Description
Individualized Homeopathic Treatment

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.

Fluoxetine

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.

Placebo

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 Total of all reporting groups

Baseline Measures
   Individualized Homeopathic Treatment   Fluoxetine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   46   43   133 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (6.4)   49.2  (5.3)   48.8  (5.8)   49  (5.8) 
Gender 
[Units: Participants]
       
Female   44   46   43   133 
Male   0   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   44   46   43   133 
Not Hispanic or Latino   0   0   0   0 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Mexico   44   46   43   133 
Baseline score in 17-item Hamilton Rating Scale for Depression [1] 
[Units: Units in Hamilton Scale]
Mean (Standard Deviation)
 21.2  (2.7)   20.6  (2.9)   20.7  (3.1)   20.8  (2.9) 
[1]

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] 
[Units: Units in Beck Depression Inventory]
Mean (Standard Deviation)
 26.3  (7.2)   25.0  (7.8)   27.0  (9.0)   26.1  (8.0) 
[1]

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] 
[Units: Units in Greene Climacteric Scale]
Mean (Standard Deviation)
 35.3  (8.5)   33.5  (10.1)   37.9  (11.5)   35.5  (10.2) 
[1]

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.



  Outcome Measures
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1.  Primary:   Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.   [ Time Frame: Baseline and 6 weeks ]

2.  Secondary:   Change From Baseline in Beck Depression Inventory at 6 Weeks.   [ Time Frame: Baseline and 6 weeks ]

3.  Secondary:   Responder Rates at 6 Weeks.   [ Time Frame: 6 weeks ]

4.  Secondary:   Change From Baseline in Greene´s Scale at 6 Weeks.   [ Time Frame: Baseline and 6 weeks ]

5.  Secondary:   Remission Rates at 6 Weeks   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: ecmc2008@hotmail.es


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