The influence of hormone replacement therapy on the cerebral serotonin-1A receptor distribution and mood in postmenopausal women - Hormone replacement therapy and serotonin-1A receptors

Conditions: Healthy postmenopausal women receiving standard hormone replacement therapy are measured using positron emission tomography to investigate the effects of hormones on the cerebral serotonin-1A receptor.

Registration Number: EUCTR2007-005685-12-AT

Lead Sponsor: niversitätsklinik für Psychiatrie und Psychotherapie, Klin. Abteilung f. Biologische Psychiatrie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

•Postmenopausal females in good condition (over 14 months of amenorrhoea)
•Age 50 - 65 years
•Uni- or Multipara
•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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, disorder 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, myomatosis, cervical smear test: PAP > II
•Extensive obesity (limiting factor is the bore of the MRI scanner)
•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.