Electrophysiological Correlates of Cognition in Depression

NCT03998748 | Terminated

• 1 other identifier: 2019P001081
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Biogenetic messages about the etiology of mental illness (e.g., the "chemical imbalance theory" of depression) are increasing but the impact that these have on decision-making and motivation is not yet clear. This study will evaluate the impact of biogenetic feedback on cognitive control and default-mode network functioning, as well as motivation for different psychiatric treatment modalities. Participants with major depressive disorder (MDD) will be instructed that they are being tested for genetic susceptibility to depression and will be randomized to receive feedback that they either do or do not have a genetic predisposition to depression. Before and after receiving this feedback, brain activity will be assessed using high-density electroencephalogram (EEG). The investigators hypothesize that those exposed to the genetic feedback condition will evidence heightened ruminative default mode network activity and perceive medications to be more effective than psychotherapy.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Default Mode Network Connectivity

  Resting-state EEG

  Through study completion (approximately at hour 4 of study)

• Error Positivity (Pe)

  Elicited between 200-500ms following an error

  Through study completion (approximately at hour 4 of study)

Secondary Outcomes (1)

• Treatment Credibility and Expectancy Questionnaire

  Through study completion (approximately at hour 4 of study)

Study Arms (2)

Experimental

EXPERIMENTAL

This group of participants will receive the feedback that they have a genetic vulnerability to depression.

Other: Sham Genetic Feedback

Control

ACTIVE COMPARATOR

This group of participants will receive the feedback that they do not have a genetic vulnerability to depression.

Other: Sham Genetic Feedback

Interventions

Sham Genetic Feedback OTHER

Participants will be told either that they have or do not have a genetic predisposition to developing depression.

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45
• Written informed consent
• BDI-II score greater than or equal to 14 (Beck et al.,1996)
• Right-handed (Chapman \& Chapman,1987)
• Normal or corrected-to-normal vision and hearing
• Fluency in written and spoken English
• Absence of any psychotropic medications for at least 2 weeks
• Absence of any psychotherapy for at least 2 weeks

You may not qualify if:

• Participants with suicidal ideation where study participation is deemed unsafe by the study clinician
• Serious or unstable medical illness (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic, autoimmune disease, etc.)
• History of seizures or seizure disorder
• Patients with psychotic features
• Current use of other psychotropic drugs
• Current use of psychotherapy
• Clinical or laboratory evidence of hypothyroidism, hyperthyroidism, or other thyroid disorder that is not controlled by medication
• Patients with a lifetime history of electroconvulsive therapy (ECT)
• Evidence of sickle cell anemia, Raynaud's disease, ulcerative skin diseases, and hemophilia
• Evidence of significant inconsistencies in self-report measures
• History or current diagnosis of dementia
• Illness receiving acute treatment at time of EEG session (e.g., taking antibiotics)
• Infections illness (either transient or chronic, such as Lyme disease) at time of EEG session
• Hairstyles that prevent application of the EEG cap (e.g., braids, dread locks, corn rows, recently dyed hair)
• History of any psychiatric genotyping

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

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MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Diego A Pizzagalli, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Depression, Anxiety and Stress Research

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 26, 2019
• Study Start: October 8, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)