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Homeopathic Treatment for Depression in Peri- and Postmenopausal Women

Information source: Hospital Juarez de Mexico
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Moderate Depression; Menopausal and Postmenopausal Disorders

Intervention: Individualized homeopathic treatment (Drug); Fluoxetine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hospital Juarez de Mexico

Official(s) and/or principal investigator(s):
Emma del Carmen Macías-Cortés, MD, PhD, Principal Investigator, Affiliation: Hospital Juárez de México

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.

Secondary outcome:

Change From Baseline in Beck Depression Inventory at 6 Weeks.

Responder Rates at 6 Weeks.

Change From Baseline in Greene´s Scale at 6 Weeks.

Remission Rates at 6 Weeks

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.

Eligibility

Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Female.

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

Locations and Contacts

Hospital Juárez de México, Mexico City 07760, Mexico
Additional Information

Related publications:

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Starting date: March 2012
Last updated: September 30, 2014

Page last updated: August 23, 2015

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