Effects of sex hormones on serotonin synthesis and degradation measured with positron emission tomography

Phase 1

• Conditions: Gender Dysphoria (Female-to-male transsexuals and male-to-female transsexuals); Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-000502-19-AT
• Lead Sponsor: Medical University of Vienna, Department of Psychiatry and Psychotherapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-19
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

•DSM-5 diagnosis of Gender Dysphoria (DSM-5: 302.85; ICD-10: F64.1)
•Somatic health based on history, physical examination, ECG, laboratory screening, SCID
•willingness and competence to sign the informed consent form

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 92
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 dysmorphic 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 which poses contraindication for MRI
•clinically relevant 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 30 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified