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

NCT04325529 | Active Not Recruiting

• 1 other identifier: 2020A000886
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression in Remission

Outcome Measures

Primary Outcomes (5)

• Clinical Interview

  For assessing psychological state

  Baseline

• Behavioral Performance on the Probabilistic Reward Task (PRT)

  The Probablilistic Reward Task assesses positive reinforcement learning.

  Baseline

• MRI Data

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

  MRI scans take place within 30 days of Screening Visit

• Salivary Cortisol

  For assessing stress level

  Baseline

• Follow-up Clinical interviews

  To assess psychological state changes

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

Study Arms (2)

remitted MDD

Unmedicated Remitted Participants with Past History of MDD

Device: Aversive stimuli

Control subjects

healthy control subjects

Device: Aversive stimuli

Interventions

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).

Also known as: no other name

Control subjects; remitted MDD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The subjects for this research will be 96 participants recruited from the community by the Center for Depression, Anxiety and Stress Research (Director: Dr. Diego Pizzagalli, Ph.D.). Participants will include: (1) 48 participants with past MDD; and (2) 48 demographically matched healthy controls.

You may qualify if:

• 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)
• History of MDD as defined by DSM-5
• Absence of anxiety disorder for the past two months

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva sample

Study Officials

• Diego Pizzagalli, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Professor, Department of Psychiatry, Harvard Medical School, Mclean Hospital

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 27, 2020
• Study Start: January 19, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)