We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
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):

June 30, 2012
July 9, 2012
September 8, 2014
September 23, 2014
October 9, 2014
March 2012
February 2014   (Final data collection date for primary outcome measure)
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).
Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks. [ Time Frame: 6 weeks ]
The measurements will be carried out at the baseline, 4 and 6 weeks of treatment course.
Complete list of historical versions of study NCT01635218 on ClinicalTrials.gov Archive Site
  • 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).
  • 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.
  • 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).
  • 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.
  • Change from baseline in Beck Depression Inventory at 6 weeks. [ Time Frame: 6 weeks ]
    The measurements will be carried out at the baseline, 4 and 6 weeks of treatment course.
  • Responder rates at 6 weeks. [ Time Frame: 6 weeks ]

    The measurements will be carried out at 4 and 6 weeks of treatment course. Response rate: decrease of 50% or more from baseline score using 17-item Hamilton Rating Scale for Depression.

    Remission rate: Hamilton Rating Scale for Depression < 7 points.

  • Change From Baseline in Greene´s Scale at 6 Weeks. [ Time Frame: 6 weeks ]
    The measurements will be carried out at the baseline, 4 and 6 weeks of treatment course.
  • Presence of adverse events during and after treatment. [ Time Frame: 4, 6 and 8 weeks ]
    Number and severity of all adverse events and homeopathic aggravations during the study period and 15 days after final dose
Not Provided
Not Provided
 
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Moderate Depression
  • Menopausal and Postmenopausal Disorders
  • 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.
    Other Names:
    • Homeopathic remedies
    • Homeopathic medicines
  • Drug: 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.
    Other Name: Prozac
  • Drug: 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.
    Other Names:
    • Fluoxetine placebo
    • Individualized homeopathic placebo
  • Experimental: Individualized homeopathic treatment
    Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
    Intervention: Drug: Individualized homeopathic treatment
  • Experimental: Fluoxetine
    Selective serotonin reuptake inhibitor.
    Intervention: Drug: Fluoxetine
  • Placebo Comparator: Placebo
    Fluoxetine placebo plus individualized homeopathic placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
March 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
40 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT01635218
HJM2030/12-A
Yes
Not Provided
Not Provided
Emma del Carmen Macías-Cortés, MD, PhD, Hospital Juarez de Mexico
Hospital Juarez de Mexico
Not Provided
Principal Investigator: Emma del Carmen Macías-Cortés, MD, PhD Hospital Juárez de México
Hospital Juarez de Mexico
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP