Status:
COMPLETED
Effects of Hormone Replacement Therapy on the Serotonergic System and Mood in Postmenopausal Women
Lead Sponsor:
Medical University of Vienna
Conditions:
Hormone Replacement
Eligibility:
FEMALE
50-65 years
Phase:
PHASE4
Brief Summary
Menopausal and postmenopausal women compose almost 20% of the Austrian population. Two thirds of all austrian women suffering from depression or anxiety disorders are over 45 years old. The serotonerg...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Postmenopausal females (over 14 months of amenorrhoea)
- Age 50 - 65 years
- Signed informed consent form
- Consent not to participate in PET or SPECT studies with an added equivalence dose of over 15 mSv within 10 years following the final assessment of the participant in this study
- Exclusion criteria
- Steroid hormone treatment within 6 months prior to the inclusion
- Current substance abuse
- History of any malign illness
- Any implant or stainless steel graft
- Concomitant neurological illness
- Concomitant psychiatric disorder except anxiety disorders or depression
- Treatment with a psychotropic agent targeting serotonin-1A and serotonin-2A receptors or the serotonin transporter such as buspirone, pindolol or SSRIs
- Clinically relevant abnormalities in the general physical examination and the routine laboratory screening
- Concomitant major illness, especially: liver disease, disorders of the endocrine system, osteoporosis (when treated with vitamine D), any clinically relevant vascular or heart diseases
- One of the following gynaecological diseases: ovariectomy, hysterectomy, endometriosis, cervical smear test: PAP \> II
- Failures to comply with the study protocol or to follow the instructions of the investigating team
- Investigations using PET or SPECT within 10 years prior to the inclusion
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00755963
Start Date
May 1 2009
End Date
July 1 2011
Last Update
July 22 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Vienna, Dept. of Psychiatry and Psychotherapy
Vienna, Vienna, Austria, 1090