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

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Mass General Brigham

Status

Active, not recruiting

Conditions

Major Depression in Remission

Treatments

Device: Aversive stimuli

Study type

Observational

Funder types

Other

Identifiers

NCT04325529
2020A000886

Details and patient eligibility

About

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.

Full 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.

Enrollment

148 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

148 participants in 2 patient groups

remitted MDD
Description:
Unmedicated Remitted Participants with Past History of MDD
Treatment:
Device: Aversive stimuli
Control subjects
Description:
healthy control subjects
Treatment:
Device: Aversive stimuli

Trial contacts and locations

1

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Central trial contact

David Crowley, ALM; Emma Palermo, BA

Data sourced from clinicaltrials.gov

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