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

NCT ID: NCT03031665

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 251 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2022-06-15

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.

Conditions

Major Depressive Disorder

Study Design

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

Study Groups

Current MDD

Subjects experiencing a current episode of Major Depressive Disorder.

No interventions assigned to this group

Remitted MDD

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

No interventions assigned to this group

Control Subjects

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Diego Pizzagalli

Professor, Department of Psychiatry, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diego A Pizzagalli, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

Other Identifiers

2016P000693

Identifier Type: -

Identifier Source: org_study_id