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NCT Number: NCT04325529

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aversive stimuli

Device

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).

Other names: no other name

Primary outcomes

  1. Clinical Interview

    Time frame: Baseline

    For assessing psychological state

  2. Behavioral Performance on the Probabilistic Reward Task (PRT)

    Time frame: Baseline

    The Probablilistic Reward Task assesses positive reinforcement learning.

  3. MRI Data

    Time frame: 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

  4. Salivary Cortisol

    Time frame: Baseline

    For assessing stress level

  5. Follow-up Clinical interviews

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

    To assess psychological state changes

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Official study title

Novel Treatment Targets For Affective Disorders Through Cross-Species Investigation of Approach/Avoidance Decision Making

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2020
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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