DepressionNCT02567110
Magnetic Resonance Spectroscopy (MRS) in Midlife Depression
An observational study of Depression and Depression Bipolar, run by Emory University at 3 sites in United States.
Trial summary
The purpose of this study is to determine the impact of inflammation on central nervous system (CNS) glutamate, white matter pathology and alterations in behavior and cognition in middle-aged patients with major depression. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Depression Bipolar
- How many people
- 169 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2016to 4 Feb 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female patients who have a diagnosis of depression or bipolar depression and men and women without a diagnosis of depression or bipolar depression in the control group
Who may be able to join
- Willing and able to give written informed consent
- Meet criteria for Major Depression per DSM-V criteria using Structured Clinical Interview for DSM-V (SCID-V) and a score ≧18 on the 17-item Hamilton Rating Scale for Depression (HAMD).
- Absence of significant suicidal ideation, determined by the Columbia Suicide Severity Rating Scale - Screen Version (CSSRS)
- Meets MRI scanning safety requirements:
- Absence of embedded MR-unsafe metallic objects
- Location and quantity of MR-safe metallic objects will minimally impact rigor/reproducibility standards of the MR data (as determined by the PI in consultation with the neuroimaging team)
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- Specific Inclusion Criteria for Controls:
- Criteria for major depression not met per the SCID-V
- HAMD scores ≦7
- Absence of any Axis I pathology
Who cannot join
- Unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease as evidenced by any of the following:
- Clinically significant abnormalities in lab values, medical history and physical exam as determined by PI or their designee
- Changes in medications prescribed for chronic medical illnesses within past 4 weeks,
- Hospitalization or drastic medical changes within past 4 weeks
- Cognitive impairment as defined by:
- Score of < 28 on Mini-mental exam (MMSE)
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- Below 8th grade reading ability as defined by Wide Range Achievement Test-3 (WRAT3) score
- Presence of psychosis (lifetime) / mania (current) as defined by:
- Lifetime diagnosis of psychotic disorders SCID-V
- SCID-V criteria for current mania/hypomania within the current episode
- Clinically significant substance abuse within the past 6 months as defined by meeting the SCID-V threshold of severity for > 4/11 criteria for substance abuse disorder
- Presence of active symptoms of an eating disorder as defined by:
- SCID-V diagnosis of Anorexia or bulimia nervosa.
- Binge eating and/or purging behavior in the absence of mood alterations or precipitating stress (bingeing within the current episode of mood symptoms will not be exclusionary)
- Presence of significant psychiatric comorbidities during current episode:
- Primary diagnosis of anxiety-spectrum disorders (panic, generalized anxiety, social phobia etc.), PTSD, OCD based on SCID-V criteria
- Severity of above diagnoses exceeds that of major depression based on assessments by the PI and the Study Team members
- Severe Axis II personality pathology as determined by a clinician
- Use of immune-active medications:
- Continuous use of prescribed, standard dose non-steroidal anti-inflammatory (NSAIDs) excluding 81 mg of aspirin within past 1 week and PRN use of NSAIDs within past 72 hours
- Intake of antibiotics within the past 2 weeks
- Immunization (including seasonal flu) within the past 2 weeks
- Use of topical or inhaled steroids within 72 hours unless otherwise approved by PI
- Use of systemic steroids (oral or parenteral) within past 6 months
- Patients taking herbal supplements with currently known effects on immune system including omega-3 supplements within 2 weeks or probiotics prior to research blood draws and scan unless approved by PI.
- Use of psychotropics:
- Daily intake of standard doses of antidepressants, mood stabilizers, antipsychotics, psychostimulants within 2 weeks (8 weeks for fluoxetine) prior to initiation of study procedures (scan and research blood sampling)
- Daily/clinically significant use of sedative-hypnotics and tranquilizers and opiates as determined by PI
- PRN use of sedative/hypnotics, benzodiazepines exceeding equivalent of clonazepam 1mg within 48 hours of study visit.
- Cancer and autoimmunity:
- Life time history of diagnosis and/or treatment of cancers other than basal cell carcinoma
- Life time history of diagnosis and/or treatment of autoimmune disorders including but not restricted to multiple sclerosis, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, and Hashimoto's thyroiditis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory Clinic
Atlanta, Georgia, 30322
Emory University Hospital Clinical Research Network
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30322
About this study
Official title: Inflammation-Induced Central Nervous System (CNS) Glutamate as a Function of Depression in Middle Age
The purpose of this study is to determine the impact of inflammation on central nervous system (CNS) glutamate, white matter pathology and alterations in behavior and cognition in middle-aged patients with major depression. Depression is associated with significant alterations in glutamate concentrations and white matter integrity, which has been associated with decreased antidepressant response, poor functional outcome, and cognitive impairment.
Read the detailed description
This study involves behavioral assessments, neurocognitive testing, blood sampling and magnetic resonance imaging (MRI) scanning. Goals of this study are to determine the impact of inflammation on glutamate concentrations in the basal ganglia and on the integrity of white matter tracts in the basal ganglia and other subcortical regions of middle-aged depressed versus non-depressed individuals and to associated the impact of glutamate and white matter changes on behavioral symptoms among the same group of patients.
- Conditions
- Depression, Depression Bipolar
- Keywords
- Mid-life Depression, Bipolar Disorder, DSM-5 MDE, Inflammation, CNS Glutamate
- Medical subject headings
- Depression, Bipolar Disorder, Inflammation
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 |
|---|---|---|
| Participants with Major Depression | Participants with major depression will complete neurocognitive and psychiatric assessments, complete self-report forms and undergo Magnetic Resonance Imaging scans. Blood and spinal fluid specimens will also be collected for estimation of inflammatory markers. | |
| Participants without Depression | Participants without depression will complete neurocognitive and psychiatric assessments, complete self-report forms and undergo Magnetic Resonance Imaging scans. Blood and spinal fluid specimens will also be collected for estimation of inflammatory markers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Glutamate in the basal ganglia
Single-voxel MRS (Magnetic Resonance Spectroscopy) scans will be done to determine the glutamate levels in the basal ganglia. MRS uses a magnetic field to look at magnetic nuclei which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra, the structure and concentrations of metabolite can be determined.
Measured: Day 1 (Day after Screening)
Secondary outcomes (3)
Neurocognitive Testing
The Cambridge Neuropsychological Test Automated Battery (CANTAB) instrument will be used to evaluate multiple cognitive domains including reaction time, attention and information processing. Findings will be compared between depressed participants and healthy controls.
Measured: Day 1 (Day after Screening)
Hamilton Rating Scale for Depression (HAM-D-17) Score
Clinician rated depression will be examined with the Hamilton Rating Scale for Depression (HAM-D-17). The HAM-D-17 is a 17-item scale used to assess present-state depression. Responses are on a 3 or 5-point scale (depending on the item) where 0 = absence of the problem and 3 or 5 = severe problem. Total raw scores range from 0 to 50 where higher scores indicate increased symptoms of depression.
Measured: Day 1 (Day after Screening)
Disease affecting white matter connecting frontal cortex to other regions of the brain
Diffusion tensor imaging (DTI) scans will be obtained to to study white matter disease in frontal cortex.
Measured: Day 1 (Day after Screening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startJul 2016
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ebrahim Haroon, Emory University
- Investigators
- Ebrahim Haroon, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567110
- Sponsor's protocol ID
- IRB00083464
- Other IDs
- 5R01MH107033-04
- Status last verified
- Feb 2023
- First submitted
- 29 Sep 2015
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation-Induced Central Nervous System (CNS) Glutamate as a Function of Depression in Middle Age
- ClinicalTrials.gov ID
- NCT02567110
- Acronym / sponsor ID
- IRB00083464
- Conditions
- Depression, Depression Bipolar
- Keywords
- Mid-life Depression, Bipolar Disorder, DSM-5 MDE, Inflammation, CNS Glutamate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2016
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 2 Oct 2015 (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.
The purpose of this study is to determine the impact of inflammation on central nervous system (CNS) glutamate, white matter pathology and alterations in behavior and cognition in middle-aged patients with major depression. Depression is associated with significant alterations in glutamate concentrations and white matter integrity, which has been associated with decreased antidepressant response, poor functional outcome, and cognitive impairment.
Detailed description
This study involves behavioral assessments, neurocognitive testing, blood sampling and magnetic resonance imaging (MRI) scanning. Goals of this study are to determine the impact of inflammation on glutamate concentrations in the basal ganglia and on the integrity of white matter tracts in the basal ganglia and other subcortical regions of middle-aged depressed versus non-depressed individuals and to associated the impact of glutamate and white matter changes on behavioral symptoms among the same group of patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Major Depression | – | –Participants with major depression will complete neurocognitive and psychiatric assessments, complete self-report forms and undergo Magnetic Resonance Imaging scans. Blood and spinal fluid specimens will also be collected for estimation of inflammatory markers. |
| Participants without Depression | – | –Participants without depression will complete neurocognitive and psychiatric assessments, complete self-report forms and undergo Magnetic Resonance Imaging scans. Blood and spinal fluid specimens will also be collected for estimation of inflammatory markers. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients who have a diagnosis of depression or bipolar depression and men and women without a diagnosis of depression or bipolar depression in the control group
Key inclusion criteria (10 listed)
- Willing and able to give written informed consent
- Meet criteria for Major Depression per DSM-V criteria using Structured Clinical Interview for DSM-V (SCID-V) and a score ≧18 on the 17-item Hamilton Rating Scale for Depression (HAMD).
- Absence of significant suicidal ideation, determined by the Columbia Suicide Severity Rating Scale - Screen Version (CSSRS)
- Meets MRI scanning safety requirements:
- Criteria for major depression not met per the SCID-V
Key exclusion criteria (32 listed)
- Unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease as evidenced by any of the following:
- Cognitive impairment as defined by:
- Presence of psychosis (lifetime) / mania (current) as defined by:
- Clinically significant substance abuse within the past 6 months as defined by meeting the SCID-V threshold of severity for > 4/11 criteria for substance abuse disorder
- Presence of active symptoms of an eating disorder as defined by:
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
Levels of Glutamate in the basal ganglia
Time frame: Day 1 (Day after Screening)
Single-voxel MRS (Magnetic Resonance Spectroscopy) scans will be done to determine the glutamate levels in the basal ganglia. MRS uses a magnetic field to look at magnetic nuclei which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra, the structure and concentrations of metabolite can be determined.
3 secondary outcomes
Neurocognitive Testing
Time frame: Day 1 (Day after Screening)
Hamilton Rating Scale for Depression (HAM-D-17) Score
Time frame: Day 1 (Day after Screening)
Disease affecting white matter connecting frontal cortex to other regions of the brain
Time frame: Day 1 (Day after Screening)
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 3 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ebrahim Haroon, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Depression Bipolar, run by Emory University at 3 sites 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 32 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 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Levels of Glutamate in the basal ganglia (time frame: Day 1 (Day after Screening)). 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 3 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.