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

Completed

• Conditions: Gender Identity Disorder
• Interventions: Drug: Hormones

• Registration Number: NCT01292785
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transsexual	Hormones	Female-to-Male and Male-to-Female Transsexuals receiving hormonal therapy

Primary Outcome Measures

Name	Time	Method
BOLD response to experimental fMRI paradigms	at baseline, 1 and 4 months after treatment start	task-related BOLD (blood oxygen level dependent) responses are evaluated before, and 4 weeks, as well as 4 months of hormonal treatment in transsexual subjects and healthy control subjects

Secondary Outcome Measures

Name	Time	Method
Psychological Questionaires	at baseline, 1 and 4 months after treatment start	Psychological questionaires measuring different aspects of emotion and cognitive processing are used to infer effects of hormonal therapy on these measures

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna; 🇦🇹 Vienna, Austria