Effects of Sex Steroids on the Serotonin System

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to prove the modulatory influence of sex hormones on serotonergic neurotransmission by determining the enzymatic processes involved in serotonin synthesis and degradation using positron emission tomography (PET) in humans in vivo with the radiotracers [11C]AMT and [11C]harmine.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Cyproterone; Cyproterone Acetate; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Lynestrenol; Methyltestosterone; Polyestradiol phosphate; Serotonin; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate; Triptorelin Pamoate

Criteria

Inclusion Criteria:

• DSM-5 diagnosis of Gender Dysphoria (DSM-5: 302.85; ICD-10: F64.1) (for transsexuals only)

• Somatic health based on history, physical examination, ECG, laboratory screening, SCID

• willingness and competence to sign the informed consent form

Exclusion Criteria:

• concomitant major medical or neurological illness

• internal or neurologic medical histories as well as pregnancy (positive urine pregnancy test) or breastfeeding

• other DSM-5 Axis-I comorbidities, determined by a structured clinical interview (SCID), especially body dysphoric disorder (DSM-5: 300.7; ICD-10: F45.22), schizophrenia spectrum and other psychotic disorders

• steroid hormone treatment within 6 months prior to inclusion

• treatment with psychotropic agents such as SSRIs

• any implant or stainless steel graft

• abnormal values in routine laboratory screening or general physical examination

• current substance abuse or current or past substance related disorder

• for participants who participated in an earlier neuroimaging study using ionizing radiation, the total radiation exposure dose of 20 mSv over the last 10 years must not be exceeded, as specified in the legislation on radiation protection (Allg. Strahlenschutzverordnung 2010; www.ris.bka.gv.at)

• failure to comply with the study protocol or to follow the instructions of the investigating team