Trial record 10 of 16 for:
Open Studies | "Premenopause"
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women (HOMDEP-MENOP)
This study is currently recruiting participants.
Verified August 2012 by Hospital Juarez de Mexico
Sponsor:
Hospital Juarez de Mexico
Information provided by (Responsible Party):
Emma del Carmen Macías-Cortés, MD, MSc, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier:
NCT01635218
First received: June 30, 2012
Last updated: August 13, 2012
Last verified: August 2012
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Purpose
The aim of this study is to determine whether individualized homeopathic treatment is more efficient than placebo or fluoxetine for moderate to severe depression in peri- and postmenopausal women.
| Condition | Intervention | Phase |
|---|---|---|
|
Moderate Depression Menopausal and Postmenopausal Disorders |
Drug: Individualized homeopathic treatment Drug: Fluoxetine Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Hospital Juarez de Mexico:
Primary Outcome Measures:
- Change from baseline in 17-item Hamilton Rating Scale for Depression at 6 weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The measurements will be carried out at the baseline, 4 and 6 weeks of treatment course.
Secondary Outcome Measures:
- Change from baseline in Beck Depression Inventory at 6 weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Number and severity of all adverse events and homeopathic aggravations during the study period and 15 days after final dose
| Estimated Enrollment: | 189 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 will be dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day prior agitation, during 10 days 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:
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Active Comparator: 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 prior agitation during 10 days). The individualized homeopathic dummy-loaded will be 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 prior agitation during 10 days). The individualized homeopathic placebo will be repeated at week 4.
Other Names:
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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 is to determine whether individualized homeopathic treatment is more efficient than placebo or fluoxetine for moderate depression in peri- and postmenopausal women.
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635218
Contacts
| Contact: Emma del Carmen Macías-Cortés, MD, MSc | +52 5747 7605 | ecmc2008@hotmail.es |
| Contact: Juan Asbun-Bojalil, MD, PhD | +52 5729 6000 ext 62823 | juanasbun@yahoo.com.mx |
Locations
| Mexico | |
| Hospital Juárez de México | Recruiting |
| Mexico City, Mexico, 07760 | |
| Contact: Emma del Carmen Macías-Cortes, MD, MSc +52 5747 7605 ecmc2008@hotmail.es | |
| Contact: Juan Asbun-Bojalil, MD,PhD +52 5729 6000 ext 62823 juanasbun@yahoo.com.mx | |
| Principal Investigator: Emma del Carmen Macías-Cortés, MD, MSc | |
Sponsors and Collaborators
Hospital Juarez de Mexico
Investigators
| Principal Investigator: | Emma del Carmen Macías-Cortés, MD, MSc | Hospital Juárez de México |
More Information
Additional Information:
Publications:
| Responsible Party: | Emma del Carmen Macías-Cortés, MD, MSc, MD, MSc, Hospital Juarez de Mexico |
| ClinicalTrials.gov Identifier: | NCT01635218 History of Changes |
| Other Study ID Numbers: | HJM2030/12-A |
| Study First Received: | June 30, 2012 |
| Last Updated: | August 13, 2012 |
| Health Authority: | Mexico: Secretaria de Salud |
Keywords provided by 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 Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013