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

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ClinicalTrials.gov Identifier: NCT03031665
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Diego A. Pizzagalli, Mclean Hospital

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.

Condition or disease
Major Depressive Disorder

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.

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Study Type : Observational
Estimated Enrollment : 144 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Sex, Hormones and GABA in Stress Induced Anhedonia in Depression
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort
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.



Primary Outcome Measures :
  1. Blood oxygen level-dependent (BOLD) activation in response to stress [ Time Frame: Baseline. ]
    Region-specific BOLD activation in response to stress in hypothalamus, amygdala, medial prefrontal cortex, orbitofrontal cortex, anterior cingulate cortex, and hippocampus


Secondary Outcome Measures :
  1. Network-specific effective connectivity [ Time Frame: Baseline ]
    Region-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

  2. GABA concentration [ Time Frame: Baseline ]
    Region-specific GABA concentration measured in rostral anterior cingulate cortex and dorsolateral prefrontal cortex



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young adults (ages 18 to 25).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031665


Contacts
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Contact: Amelia Moser, BS 617-855-4431 amoser@mclean.harvard.edu
Contact: David J Crowley, ALM 617-855-4432 djcrowley@mclean.harvard.edu

Locations
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United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Nara Nascimento, BA    617-855-4420    nnascimento@mclean.harvard.edu   
Principal Investigator: Diego Pizzagalli, PhD         
Sponsors and Collaborators
Mclean Hospital
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
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Principal Investigator: Diego A Pizzagalli, Ph.D. Mclean Hospital
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Responsible Party: Diego A. Pizzagalli, Professor, Department of Psychiatry, Harvard Medical School, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03031665    
Other Study ID Numbers: 2016P000693
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diego A. Pizzagalli, Mclean Hospital:
GABA
Depression
Stress
Androgens
Additional relevant MeSH terms:
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Anhedonia
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases