Clinical trial NCT01635218: Homeopathic Treatment for Depression in Peri- and Postmenopausal Women
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate Depression
Menopausal and Postmenopausal Disorders
Keywords: Depression
Perimenopause
Postmenopause
Homeopathy
Lead sponsor: Hospital Juarez de Mexico
Sponsor class: OTHER_GOV
First posted: 2012-07-09
Enrollment: 133
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change From Baseline in Beck Depression Inventory at 6 Weeks.
timeFrame: Baseline and 6 weeks
measure: Responder Rates at 6 Weeks.
timeFrame: 6 weeks
measure: Change From Baseline in Greene´s Scale at 6 Weeks.
timeFrame: Baseline and 6 weeks
measure: Remission Rates at 6 Weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Juárez de México
Study officials:
affiliation: Hospital Juárez de México
name: Emma del Carmen Macías-Cortés, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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