Status:
COMPLETED
Tibolone and Placebo in Adjunct to Antidepressant Medication for Women With Menopausal Depression
Lead Sponsor:
The Alfred
Conditions:
Menopausal Depression
Eligibility:
FEMALE
45-65 years
Phase:
PHASE4
Brief Summary
Longitudinal epidemiological studies have shown that many women experience significant physical and psychological changes as they approach menopause and for a long time following. Vasomotor symptoms (...
Detailed Description
All women experience menopause and a significant number suffer from ongoing, severe depression beginning with the major hormone fluctuations in this middle stage of life. Longitudinal epidemiological ...
Eligibility Criteria
Inclusion
- Females who are currently physically well and between 45 and 65 years of age
- Current DSM-IV diagnosis of depression disorder
- Able to give informed consent
- Menopausal as determined by standardized classification guidelines for female reproductive aging were proposed at the Stages of Reproductive (STRAW) -Aging Workshop and symptom profile on the STRAW
- First-onset or relapse depression during menopause
- Currently taking either an SSRI or SNRI, or no psychotropic medication at all
- Evidence of a normal mammogram in the preceding 12 months.
Exclusion
- Patients with known abnormalities in the hypothalamic-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event, breast pathology, undiagnosed vaginal bleeding or abnormal Pap smear results in the previous 2 years.
- Patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; or the presence of illness causing immobilisation.
- Patients experiencing severe melancholia, neurovegetative symptoms or current suicidality necessitating acute hospitalisation or intensive psychiatric treatment.
- Patients with psychotic symptoms or past history of severe mental illness including schizophrenia.
- Use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including Tibolone or use of phytoestrogen supplements as powder or tablet
- Pregnancy / Lactation
- Smoking cigarettes or other nicotine products
- Illicit drug use
- More than 3 standard drinks per day
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01470092
Start Date
July 1 2012
End Date
December 1 2017
Last Update
January 9 2020
Active Locations (1)
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1
The Alfred Hospital
Melbourne, Victoria, Australia, 3181