Major Depression in Remission
Conditions
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 collected through MRI and behavioral tasks will be used to predict depressive symptoms in the future.
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; (3) neural markers that prospectively predict disease course. This will be achieved through an innovative method of using functional magnetic resonance imaging (fMRI) during an approach/avoidance decision-making task.
Interventions
DEVICEAversive stimuli
Electrotactile stimulation will be used as the aversive stimulus. The aversive stimulus is delivered in the form of a mild half-second stimulation to the ankle, calibrated to a subjective threshold that is uncomfortable but not painful. This stimulation is delivered by Digitimer DS8R Constant Current Stimulator (Digitimer North America, LLC. Ft. Lauderdale, FL). Its previous model DS71 has been safely implemented in studies with previously MGH-approved IRB's (Milad et al., 2013).
Sponsors
Mclean Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Interview | Baseline | For assessing psychological state |
| Behavioral Performance on the Probabilistic Reward Task (PRT) | Baseline | The Probablilistic Reward Task assesses positive reinforcement learning. |
| MRI Data | MRI scans take place within 30 days of Screening Visit | For testing the neural correlates of approach-avoidance decision making behaviors in a trans-diagnostic sample |
| Salivary Cortisol | Baseline | For assessing stress level |
| Follow-up Clinical interviews | Change from Baseline at 6 months and 12 months after the MRI scanning visit | To assess psychological state changes |
Countries
United States
Outcome results
None listed