Effects of Sex Steroid Hormones on Human Brain Function, Structure and Connectivity

Medical University of Vienna

Status

Completed

Conditions

Gender Identity Disorder

Treatments

Drug: Hormones

Study type

Observational

Funder types

Other

Identifiers

NCT01292785

P23021FWF

Details and patient eligibility

About

This ultrahigh-field MRI study gives us the unique opportunity to measure changes in brain function and structure induced by long-term opposite-sex steroid hormone administration in transsexual subjects. Our aim is 1. to prove the influence of high-dose, long-term opposite-sex steroid hormone treatment on functional brain response in transsexuals. 2. to investigate the influence of hormone treatment on resting state functional connectivity and brain morphology. 3. to investigate differences between transsexuals and healthy control subjects in brain function and functional connectivity, brain morphology and structural connectivity. In this longitudinal study, transsexuals and healthy control subjects will undergo three 7 Tesla ultrahigh-field MRI scan sessions: 1. baseline (before hormone treatment), 2. after 4 weeks of treatment and 3. after 4 months of treatment.

Enrollment

80 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for transsexuals are:

DSM-IV diagnosis of Gender Identity Disorder (DSM-IV: 302.85, 302.6; ICD-10: F64.9, F64.8) by a structured clinical interview (SCID)
general health based on history, physical examination, ECG, laboratory screening, SCID
willingness and competence to sign the informed consent form

Exclusion criteria for transsexuals are:

severe neurological or internal diseases
steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones)
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 (determined using drug screening at the screening visit)
pregnancy (determined at screening visit and first MRI scan)
failure to comply with the study protocol or to follow the instructions of the investigating team.

Inclusion criteria for healthy controls are:

general health based on history, physical examination, ECG, laboratory screening, SCID
willingness and competence to sign the informed consent form

Exclusion criteria for healthy controls are:

severe diseases
any implant or stainless steel graft
steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones)
abnormal values in routine laboratory screening or general physical examination
current substance abuse (determined using drug screening at the screening visit)
pregnancy (determined at screening visit and first MRI scan)
failure to comply with the study protocol or to follow the instructions of the investigating team