Homeopathic Treatment for Depression in Peri- and Postmenopausal Women

Phase 2

Completed

Conditions: Moderate Depression
Menopausal and Postmenopausal Disorders

Interventions: Drug: Placebo
Drug: Individualized homeopathic treatment
Drug: Fluoxetine

Registration Number: NCT01635218

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 133

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Fluoxetine placebo plus individualized homeopathic placebo
Individualized homeopathic treatment	Individualized homeopathic treatment	Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Fluoxetine	Fluoxetine	Selective serotonin reuptake inhibitor.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.	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

Name	Time	Method
Change From Baseline in Beck Depression Inventory at 6 Weeks.	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).
Responder Rates at 6 Weeks.	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.
Change From Baseline in Greene´s Scale at 6 Weeks.	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).
Remission Rates at 6 Weeks	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.