Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT01635218
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT01635218
Study Brief:
Protocol Section:
NCT01635218