Phase 2
N=133
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women
Moderate Depression · Menopausal and Postmenopausal Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01635218 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks. — 9.9; 11.7; 15 Units in Hamilton Scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Individualized homeopathic treatment (Drug); Fluoxetine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Hospital Juarez de Mexico
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks. |
9.9; 11.7; 15 | <0.05 sig |
| SECONDARY Change From Baseline in Beck Depression Inventory at 6 Weeks. |
12; 14.2; 15.5 | 0.14 |
| SECONDARY Responder Rates at 6 Weeks. |
24; 19; 5 | <0.05 sig |
| SECONDARY Change From Baseline in Greene´s Scale at 6 Weeks. |
18.1; 23.1; 26.8 | 0.002 sig |
| SECONDARY Remission Rates at 6 Weeks |
7; 7; 2 | 0.10 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01635218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.