Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.2 (Stress Manipulation)

N/AActive Not RecruitingNCT04325529

Mclean Hospital148 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

148

Conditions

Major Depression in Remission

Interventions

Aversive stimuliDEVICE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

McLean Hospital

Belmont, Massachusetts, United States

Outcomes

Primary Outcomes

Clinical Interview

For assessing psychological state

Time frame: Baseline

Behavioral Performance on the Probabilistic Reward Task (PRT)

The Probablilistic Reward Task assesses positive reinforcement learning.

Time frame: Baseline

MRI Data

For testing the neural correlates of approach-avoidance decision making behaviors in a trans-diagnostic sample

Time frame: MRI scans take place within 30 days of Screening Visit

Salivary Cortisol

For assessing stress level

Time frame: Baseline

Follow-up Clinical interviews

To assess psychological state changes

Time frame: Change from Baseline at 6 months and 12 months after the MRI scanning visit

Data from ClinicalTrials.gov

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