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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

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.

Condition or disease Intervention/treatment Phase
Moderate Depression Menopausal and Postmenopausal Disorders Drug: Individualized homeopathic treatment Drug: Fluoxetine Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

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.
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

Experimental: Fluoxetine
Selective serotonin reuptake inhibitor.
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

Placebo Comparator: Placebo
Fluoxetine placebo plus individualized homeopathic placebo
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635218


Locations
Mexico
Hospital Juárez de México
Mexico City, Mexico, 07760
Sponsors and Collaborators
Hospital Juarez de Mexico
Investigators
Principal Investigator: Emma del Carmen Macías-Cortés, MD, PhD Hospital Juárez de México

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emma del Carmen Macías-Cortés, MD, PhD, MD, PhD, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier: NCT01635218     History of Changes
Other Study ID Numbers: HJM2030/12-A
First Posted: July 9, 2012    Key Record Dates
Results First Posted: September 23, 2014
Last Update Posted: October 9, 2014
Last Verified: September 2014

Keywords provided by Emma del Carmen Macías-Cortés, MD, PhD, Hospital Juarez de Mexico:
Depression
Perimenopause
Postmenopause
Homeopathy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors