Study Stopped
The funding agency, the NICHD, did not make a non-competing continuation award for the fifth and final year of the project and moved the grant into closeout.
Gender Identity and Own Body Perception
1 other identifier
observational
132
1 country
1
Brief Summary
This study will provide valuable information on the neurobiological underpinning of gender dysphoria (GD) and the effects of sex hormones, and promises to uncover functional or structural neural patterns that could predict outcome in terms of body image and quality of life after cross-sex hormone treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2018
CompletedFirst Submitted
Initial submission to the registry
April 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 22, 2023
March 1, 2023
2.9 years
April 19, 2020
March 20, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence
Own body perception in relation to functional and structural connection
Baseline Visit 2 pre hormone treatment
Morphometric differences by sex, gender identity and sexual orientation
Cortical thickness, surface area, cortical and subcortical structural volumes and white matter tracts measured by MRI in relation to sex and gender identity and sexual orientation.
Baseline Visit 2 pre hormone treatment
Brain activation during own body perception
Images of body morph test presented during fMRI scan
Baseline Visit 2 pre hormone treatment
Change in cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence
Own body perception in relation to functional and structural connection
Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Change in morphometric differences by sex, gender identity and sexual orientation
Cortical thickness, surface area, cortical and subcortical structural volumes and white matter tracts measured by MRI in relation to sex and gender identity and sexual orientation.
Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Change in brain activation during own body perception
Images of body morph test presented during fMRI scan
Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Study Arms (6)
trans men
fMRI: body morph test and neurocognitive testing
trans women
fMRI: body morph test and neurocognitive testing
homosexual cisgender men
fMRI: body morph test and neurocognitive testing
homosexual cisgender women
fMRI: body morph test and neurocognitive testing
cisgender women
fMRI: body morph test and neurocognitive testing
cisgender men
fMRI: body morph test and neurocognitive testing
Interventions
fMRI: body morph test and neurocognitive testing
Eligibility Criteria
Investigators will enroll 150 participants between the ages of 18 and 40 (25 trans males; 25 trans females; 25 cis gender females; 25 cis gender males; 25 homosexual males; 25 homosexual females)
You may qualify if:
- Females and males from any racial or ethnic background, between the ages of 18 years and 40 years.
- Participants must meet Diagnostic and Statistical Manual-5 criteria for GD (302.85)
- Intelligence quotient (IQ) \> 80
- Participants with GD
You may not qualify if:
- Previous or on-going sex hormone medication
- Previous sex reassignment surgery
- Oral contraceptives
- Participants with GD are not be taking any other psychotropic medication. (No participant will be recommended to discontinue or taper medications for the purpose of participating in the study.)
- Irregular menstrual cycles
- Control participants
- Females and males from any racial or ethnic background, between the ages of 18 and 40.
- IQ \> 80
- Control participants
- Psychiatric medications
- A score of ≥ 1 standard deviation higher than population norms on the MADRS depression or the Hamilton anxiety scale (HAMA)
- Sex hormone treatment
- Irregular menstrual cycles
- Any known chromosomal or hormonal disorder
- Current substance abuse or dependence
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry and Biobehavioral Sciences
Study Record Dates
First Submitted
April 19, 2020
First Posted
May 5, 2020
Study Start
February 22, 2018
Primary Completion
February 1, 2021
Study Completion
December 31, 2021
Last Updated
March 22, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share