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

Primary Purpose

Moderate Depression, Menopausal and Postmenopausal Disorders

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Individualized homeopathic treatment
Fluoxetine
Placebo
Sponsored by
Hospital Juarez de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Depression focused on measuring Depression, Perimenopause, Postmenopause, Homeopathy

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Juárez de México

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Individualized homeopathic treatment

Fluoxetine

Placebo

Arm Description

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

Selective serotonin reuptake inhibitor.

Fluoxetine placebo plus individualized homeopathic placebo

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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).
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.

Full Information

First Posted
June 30, 2012
Last Updated
September 30, 2014
Sponsor
Hospital Juarez de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01635218
Brief Title
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Juarez de Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Depression, Menopausal and Postmenopausal Disorders
Keywords
Depression, Perimenopause, Postmenopause, Homeopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized homeopathic treatment
Arm Type
Experimental
Arm Description
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Arm Title
Fluoxetine
Arm Type
Experimental
Arm Description
Selective serotonin reuptake inhibitor.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Fluoxetine placebo plus individualized homeopathic placebo
Intervention Type
Drug
Intervention Name(s)
Individualized homeopathic treatment
Other Intervention Name(s)
Homeopathic remedies, Homeopathic medicines
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Fluoxetine placebo, Individualized homeopathic placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Beck Depression Inventory at 6 Weeks.
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
Title
Responder Rates at 6 Weeks.
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
Title
Change From Baseline in Greene´s Scale at 6 Weeks.
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
Title
Remission Rates at 6 Weeks
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma del Carmen Macías-Cortés, MD, PhD
Organizational Affiliation
Hospital Juárez de México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Juárez de México
City
Mexico City
ZIP/Postal Code
07760
Country
Mexico

12. IPD Sharing Statement

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Homeopathic Treatment for Depression in Peri- and Postmenopausal Women

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