Status:
ACTIVE_NOT_RECRUITING
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.2 (Stress Manipulation)
Lead Sponsor:
Mclean Hospital
Conditions:
Major Depression in Remission
Eligibility:
All Genders
18-45 years
Brief Summary
This study investigates how remitted individuals with past major depressive disorder (MDD) make approach-avoidance decisions and which brain regions are implicated in such decisions. Information colle...
Detailed Description
The overarching goals of this research are to investigate: (1) neural substrates of approach/avoidance behaviors in remitted MDDs; (2) stress-induced signaling in remitted individuals with past MDD; (...
Eligibility Criteria
Inclusion
- Inclusion Criteria for all participants:
- All genders, races, and ethnic origins, aged between 18 and 45
- Capable of providing written informed consent, and fluent in English
- Right-handed
- Absence of any psychotropic medications for at least 2 weeks
- Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)
- Inclusion Criteria for "Remitted MDD" group:
- Meets inclusion criteria for all subjects, plus:
- History of MDD as defined by DSM-5
- Absence of anxiety disorder for the past two months
- Exclusion Criteria for all participants:
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, or partner with vasectomy)
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- History of seizure disorder
- History of psychiatric illnesses, other than depression or anxiety disorders among the Current MDD and Remitted MDD groups
- 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
- History of cocaine or stimulant use or dopaminergic drugs
- History or current diagnosis of dementia, or a score of \< 26 on the Mini Mental State Examination at the screening visit;
- Patients with mood congruent or mood incongruent psychotic features
- Current use of other psychotropic drugs
- Clinical or laboratory evidence of hypothyroidism
- Patients with a lifetime history of electroconvulsive therapy (ECT)
- Failure to meet standard MRI safety requirements
- Abnormal ECG and lab results
- History of seizure disorder
Exclusion
Key Trial Info
Start Date :
January 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04325529
Start Date
January 19 2021
End Date
June 30 2026
Last Update
December 12 2025
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478