Major Depressive DisorderNCT03031665
Sex, Hormones and Gamma-Aminobutyric Acid (GABA) in Stress Induced Anhedonia in Depression
An observational study of Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 15 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young adults (ages 18 to 25).
Who may be able to join
- 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 inclusion criteria for all subjects, plus:
Show all 10Show fewer
- 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).
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sex, Hormones and GABA in Stress Induced Anhedonia in Depression
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.
Read the 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
- Keywords
- GABA, Depression, Stress, Androgens
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline.
Secondary outcomes (2)
Network-specific effective connectivity
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
Measured: Baseline
GABA concentration
Region-specific GABA concentration measured in rostral anterior cingulate cortex and dorsolateral prefrontal cortex
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start1 Oct 2017
- Primary completion30 Apr 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Responsible party
- Principal investigator, Diego Pizzagalli, Mclean Hospital
- Investigators
- Diego A Pizzagalli, Ph.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031665
- Sponsor's protocol ID
- 2016P000693
- Status last verified
- Mar 2024
- First submitted
- 20 Jan 2017
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex, Hormones and GABA in Stress Induced Anhedonia in Depression
- ClinicalTrials.gov ID
- NCT03031665
- Acronym / sponsor ID
- 2016P000693
- Conditions
- Major Depressive Disorder
- Keywords
- GABA, Depression, Stress, Androgens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young adults (ages 18 to 25).
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Network-specific effective connectivity
Time frame: Baseline
GABA concentration
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego A Pizzagalli, Ph.D. principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygen level-dependent (BOLD) activation in response to stress (time frame: Baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.