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

NCT03031665 | Completed

• 1 other identifier: 2016P000693
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

GABA; Depression; Stress; Androgens

Outcome Measures

Primary Outcomes (1)

• Blood oxygen level-dependent (BOLD) activation in response to stress

  Region-specific BOLD activation in response to stress in hypothalamus, amygdala, medial prefrontal cortex, orbitofrontal cortex, anterior cingulate cortex, and hippocampus

  Baseline.

Secondary Outcomes (2)

• Network-specific effective connectivity

  Baseline

• GABA concentration

  Baseline

Study Arms (3)

Current MDD

Subjects experiencing a current episode of Major Depressive Disorder.

Remitted MDD

Subjects who have a history of Major Depressive Disorder, but have not had a depressive episode for at least two months.

Control Subjects

Subjects who have no history of clinical depression or other psychological disorder.

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young adults (ages 18 to 25).

You may qualify if:

• 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
• 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).
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mclean Hospital: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Diego A Pizzagalli, Ph.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry, Harvard Medical School

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 25, 2017
• Study Start: October 1, 2017
• Primary Completion: April 30, 2022
• Study Completion: June 15, 2022
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)