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

Hospital Juarez de Mexico

Status and phase: Completed; Phase 2

Conditions: Moderate Depression; Menopausal and Postmenopausal Disorders

Treatments: Drug: Fluoxetine; Drug: Placebo; Drug: Individualized homeopathic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01635218

HJM2030/12-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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133 participants in 3 patient groups, including a placebo group

Individualized homeopathic treatment

Experimental group

Description:

Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.

Treatment:

Drug: Individualized homeopathic treatment

Fluoxetine

Experimental group

Description:

Selective serotonin reuptake inhibitor.

Treatment:

Drug: Fluoxetine

Placebo

Placebo Comparator group

Description:

Fluoxetine placebo plus individualized homeopathic placebo

Treatment:

Drug: Placebo