Comparative Study of Gender Identity Disorder Versus Control

NCT ID: NCT04935164

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-26
• Study Completion Date: 2029-12-31

Brief Summary

Gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity.

Detailed Description

Gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity. Gender dysphoria is accompanied by the often overwhelming need for a hormonal or even hormone-surgical transition. Gender dysphoria is very often characterized by fluctuating mood sadness, irritability, obsessionality. An improvement in the quality of life after medical treatment (hormone therapy) and gender reassignment surgery has been described in the literature. Morphological similarities have been found between the brains of women and the brains of so-called transgender women, as well as between the brains of transgender men and men. These morphological data are only very fragmentary and have not been supported by neuro-functional data. Self-awareness, which refers to the awareness that an individual has of his body, his image and his own identity, is partly underpinned, at the brain level, by the activation of the Default Mode Network (DMN) at rest, in non-pathological conditions. The conflict between the internal perception of the own body and its objective representation could result in a change in brain connectivity within the DMN, due in particular to changes in the activation of the temporo parietal junction.

Conditions

Gender Dysphoria, Adult

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Male patients with gender dysphoria

• male patients with gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation
• patients without psychotropic treatments
• patients who do not benefit of hormone therapy
• patients who have not yet received gender reassignment surgery
• patients aged 18 to 60 years
• patients with normal or corrected vision
• patients without mental defect
• patients without neurological impairment

Psychiatric evaluations

Intervention Type: OTHER

At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes

Female patients with gender dysphoria

• female patients with gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation
• patients without psychotropic treatments
• patients who do not benefit of hormone therapy
• patients who have not yet received gender reassignment surgery
• patients aged 18 to 60 years
• patients with normal or corrected vision
• patients without mental defect
• patients without neurological impairment

Psychiatric evaluations

Intervention Type: OTHER

At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes

Male volunteers without gender dysphoria

• male volunteer without gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation
• volunteer aged 18 to 60 years
• volunteer with normal or corrected vision
• volunteer without mental defect
• volunteer without neurological impairment

Psychiatric evaluations

Intervention Type: OTHER

At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes

Female volunteers without gender dysphoria

• female volunteer without gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation
• volunteer aged 18 to 60 years
• volunteer with normal or corrected vision
• volunteer without mental defect
• volunteer without neurological impairment

Psychiatric evaluations

Intervention Type: OTHER

At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes

Interventions

Psychiatric evaluations

At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes

Intervention Type: OTHER

Other Intervention Names

Electroencephalography; Double Mirror Test; Mini International Neuropsychiatric Interview; Montgomery-Åsberg Depression Rating Scale; Hamilton Rating Scale for Depression

Eligibility Criteria

Inclusion Criteria

• Patients with gender dysphoria
• Without psychotropic
• Without hormono-therapy
• Without sexual surgery assignation

Exclusion Criteria

• Any depression
• Any addiction

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Henri Laborit

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Henri Laborit

Poitiers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Bérangère Thirioux, PhD

Role: CONTACT

berangere.thirioux@ch-poitiers.fr

0033 5 49 44 58 56

Facility Contacts

Bérangère Thirioux, PhD

Role: primary

berangere.thirioux@ch-poitiers.fr

Other Identifiers

2020-A03407-32

Identifier Type: -

Identifier Source: org_study_id