Skip to content

Sex, Hormones and Gamma-Aminobutyric Acid (GABA) in Stress Induced Anhedonia in Depression

Sex, Hormones and GABA in Stress Induced Anhedonia in Depression

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03031665
Enrollment
251
Registered
2017-01-25
Start date
2017-10-01
Completion date
2022-06-15
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

GABA, Depression, Stress, Androgens

Brief summary

Using an innovative multi-modal imaging approach, this study investigates the role of the neurochemical gamma-aminobutyric acid (GABA), brain activity, as well as hormones in understanding sex differences in Major Depressive Disorder (MDD). Further, the investigators will link these markers to symptoms of depression.

Detailed description

The goals of this research are to investigate: (1) functional and neurochemical features associated with depression irrespective of clinical state; (2) moderating effects of hormones on stress circuitry in MDD; and (3) sex differences in symptoms. To this end, the study is enrolling adults with current depression and remitted depression, along with a control group of psychiatrically health adults. Participants will have an magnetic resonance imaging (MRI) exam involving multiple imaging techniques (functional, structural, spectroscopic) while performing computer-based tests. Additional questionnaires and tests will be done outside the scanner to assess current symptoms and hormone levels. The integration of laboratory-based measures of reward and stress sensitivity, with state-of-the-art imaging techniques and hormonal assessments promises to provide novel insights in the sex-dependent manifestation and pathophysiology of MDD.

Interventions

None listed

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Mclean Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

for all participants. * Males and females aged 18 through 25 * Capable of providing written informed consent, and fluent in English * Right-handed * Absence of any psychotropic medications for at least 2 weeks * Female subjects will be scheduled to participate during the follicular phase of their menstrual cycle Inclusion Criteria for Current MDD group: * Meets inclusion criteria for all subjects, plus: * Meets diagnostic criteria for a current episode of Major Depressive Disorder (MDD), as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Inclusion Criteria for Remitted MDD group: * Meets inclusion criteria for all subjects, plus: * History of MDD as defined by DSM-5, but in remission for the past two months * Absence of anxiety disorder for the past two months

Exclusion criteria

for all participants: * History of psychiatric illnesses, other than depression or anxiety disorders among the Current MDD and Remitted MDD groups. * History of psychotic episodes, suicidal ideation, or of electroconvulsive therapy (ECT) treatment * Use of hormone replacement therapy, or of anabolic steroids. * Use of hormonal contraceptives is permitted for female subjects only if the subject has regular menses * Failure to meet any MRI safety requirements * Serious or unstable medical illness, or history of neurological disease or damage * History of use of cocaine, stimulants, or dopaminergic drugs * History of substance use disorder or alcohol use disorder (as these terms are defined by DSM-5); except depressed subjects may have a history of 'Mild' substance/alcohol use disorder only if it ended as least 12 months ago.

Design outcomes

Primary

MeasureTime frameDescription
Blood oxygen level-dependent (BOLD) activation in response to stressBaseline.Region-specific BOLD activation in response to stress in hypothalamus, amygdala, medial prefrontal cortex, orbitofrontal cortex, anterior cingulate cortex, and hippocampus

Secondary

MeasureTime frameDescription
Network-specific effective connectivityBaselineRegion-specific resting state connectivity of two networks (1) hypothalamus and amygdala, with medial prefrontal cortex and orbitofrontal cortex; and (2) hypothalamus and amygdala, with hippocampus
GABA concentrationBaselineRegion-specific GABA concentration measured in rostral anterior cingulate cortex and dorsolateral prefrontal cortex

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026