Clinical trial NCT04374708: Gender Identity and Own Body Perception
Official title: Gender Identity and Own Body Perception- Implications for the Neurobiology of Gender Dysphoria
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gender Dysphoria
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.

Detailed description: The purpose of this study is to understand the neurobiology of gender dysphoria (GD) and the interactions between cross hormone treatment, the brain, and the body phenotype. The investigators also aim to identify pre-treatment neurobiological and other factors to help predict body congruence and quality of life outcomes from hormone treatment. There is mounting interest in gender identity issues worldwide, as requests for gender-confirming treatments have increased in the past 3 decades, and alarmingly high suicide rates have recently been reported in those with GD. Despite this, little is known about neurobiological or other etiological factors contributing to GD or gender incongruence. This study will address a core feature of GD that has been little studied in terms of the neurobiology: the incongruence between perception of self and one's own body.

Eligibility criteria: Participants with gender dysphoria (GD)

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Inclusion Criteria:

* Females and males from any racial or ethnic background, between the ages of 18 and 40.
* IQ \> 80

Control participants

Exclusion Criteria:

* 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

Exclusion criteria for all participants:

* Any known chromosomal or hormonal disorder
* Current substance abuse or dependence
* Current neurological disorder or psychiatric disorder
* Pregnancy
* Current major medical disorders that may affect cerebral metabolism such as diabetes or thyroid disorders
* Head trauma associated with loss of consciousness
* HIV positive individuals
* Individuals with ferromagnetic metal implantations or devices. This includes any electronic implants or devices, braces, infusion pumps, aneurysm clips, metal fragments or foreign bodies, metal prostheses, joints, rods or plates
* Visual acuity worse than 20/35 for each eye as determined by Snellen close vision acuity chart. Acuity may be met with corrective lenses

Primary outcomes:
measure: cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence
timeFrame: Baseline Visit 2 pre hormone treatment
measure: Morphometric differences by sex, gender identity and sexual orientation
timeFrame: Baseline Visit 2 pre hormone treatment
measure: Brain activation during own body perception
timeFrame: Baseline Visit 2 pre hormone treatment
measure: Change in cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence
timeFrame: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
measure: Change in morphometric differences by sex, gender identity and sexual orientation
timeFrame: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
measure: Change in brain activation during own body perception
timeFrame: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
References: