- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04713722
Early Life Stress and Depression: Molecular and Functional Imaging (ELS)
Study Overview
Status
Conditions
Detailed Description
Epidemiological studies have shown that severe childhood adversity explains 32-44% of psychiatric disorders, and is associated with 4.6-fold risk for MDD later in life. In spite of these epidemiological data, the neurobiological underpinnings associated with maladaptive sequelae of severe childhood adversity as well as resilience remain largely unknown.
Preclinical research suggests that early adversity leads to (1) structural abnormalities in brain regions critically implicated in stress regulation; (2) increased oxidative stress; and (3) glutamatergic abnormalities. The current research protocol is designed to prospectively test the contributions of these abnormalities in individuals exposed to severe childhood adversity.
Improving our understanding of neurobiological mechanisms associated with different childhood adversity outcomes is of paramount importance in order to (1) identify individuals at risk for psychopathology and maladaptive behavior, (2) prevent re-victimization, and (3) develop more targeted therapeutic interventions.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Aliza Brown
- Phone Number: 617-855-2589
- Email: abrown98@mclean.harvard.edu
Study Contact Backup
- Name: Lauren Hutson
- Phone Number: 617-855-4439
- Email: lhutson@mclean.harvard.edu
Study Locations
-
-
Massachusetts
-
Belmont, Massachusetts, United States, 02478
- Recruiting
- McLean Hospital
-
Contact:
- David Crowley
- Phone Number: 617-855-4432
- Email: djcrowley@mclean.harvard.edu
-
Principal Investigator:
- Diego Pizzagalli, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Females of all races and ethnic origins
- Ages from 20 to 32
- Right-handed
- Capable of providing written informed consent
- Currently unmedicated. Note that this criterion applies at enrollment only, and subjects will be informed that they can continue to be in the study if they begin a new medication after enrollment.
- Normal or corrected-to-normal vision and hearing
- Fluency in written and spoken English
- Absence of first-degree relatives with a history of a psychotic disorder or psychotic symptoms; (adopted individuals are eligible to participate but we will probe about family history in case such information is available to the adopted subject)
Exclusion Criteria:
- Participants with suicidal ideation where continued study participation is deemed unsafe by the study clinician (these participants will be immediately referred to appropriate clinical treatment)
- Pregnant women, or women of childbearing potential who have a positive result on a urine pregnancy test
- Failure to meet MRI safety requirements including but not limited to any metal implants or prostheses that cannot be removed, or exposure to shrapnel
- Claustrophobia or severe anxiety that might impact participation in neuroimaging
- Injury or movement disorder that may make it difficult to lie still in the scanner
- Any current recreational/illicit drug use as assessed by a urine drug test (covering cocaine, cannabinoids, opiates, amphetamines, methamphetamines, phencyclidine, MDMA, benzodiazepines, methadone, oxycodone, tricyclic antidepressants, and barbiturates)
- Use of drug or herbal supplement for depression (e.g., St. John's Wort or SAMe) of those that could affect stress response
- Use of any medication in the 24 hours prior to the Scanning procedure (including antibiotics, asthma inhalants, pain relievers, antihistamines, or over-the-counter medications).
- Recent use (within 3 weeks) or any medication that affects blood flow or blood pressure, or which is vasodilating/vasoconstricting
- Use of Melatonin within 5 days of the Scanning procedure
- Metformin use in the past 6 months (for either clinical care or as part of research)
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine (hypothyroidism), neurologic, autoimmune disease (such as Lyme, Crohn's), or hematologic disease
- Current infectious illness (either transient or chronic); Current episode of allergic reaction or asthma
- Hemophilia; Diabetes with poor glucose control; History of chronic migraine (> 15 days/mo.); History or current diagnosis of dementia
- History of seizure disorder
- Any history of significant head injury or concussion
- Past/current DSM-5 diagnosis of: OCD, ADHD, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders NOS, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, autism or any other pervasive developmental disorder, organic mental disorder, anorexia, binge eating disorder or bulimia (however a history of bulimia or binge eating disorder is allowable if it has been in remission for at least two years)
- History of moderate or severe substance or alcohol use disorder; or, mild substance or alcohol use disorder within the last 12 months (with the exception of cocaine or stimulant abuse, which will lead to automatic exclusion).
- History of ECT
- Patient is clinically unstable, in the judgment of the clinician
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
MDD/childhood adversity group
subjects with current MDD who experienced childhood adversity
|
rMDD/ childhood adversity
subjects with a history of MDD who experienced childhood adversity
|
MDD
subjects in a current episode of MDD, with no history of childhood adversity
|
Healthy Control
healthy control subjects, with no history of childhood adversity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immuno-oxidative abnormalities
Time Frame: Baseline
|
Redox ratio and glutamate metabolites in the prefrontal cortex
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood oxygen level dependent (BOLD) activation
Time Frame: Baseline
|
Prefrontal cortex activation during a reward task
|
Baseline
|
Blood oxygen level dependent (BOLD) activation in emotional processing
Time Frame: Baseline
|
Prefrontal cortex activation during an emotional processing task
|
Baseline
|
Peripheral inflammation
Time Frame: Baseline
|
Stress-related pro-inflammatory transcription control pathways
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Diego Pizzagalli, PhD, McLean Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P001470
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Lawson Health Research InstituteTerminated