Neuroimaging Study for Decoding Emotional States and Identifying Neural Circuits to Disengage From Negative Thinking

NCT06254144 | Completed

• 1 other identifier: 2022-006
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to decode different thinking states from the brain activation patterns and identify the neural circuits that disengage from these thinking patterns using functional magnetic resonance imaging (fMRI) measurement in individuals with major depressive disorder.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (2)

• Classification accuracy of different internal thoughts

  fMRI brain images captured during various internal thought processes are used as input to a machine learning classifier. This classifier is trained to discriminate between different mental states. In this context, "classification accuracy" refers to the classifier's ability to accurately identify or predict the specific mental state based on the fMRI data. This measures the classifier's effectiveness in differentiating between mental states by analyzing patterns of brain activity. Classification accuracy is assessed using the area under the receiver operating characteristic curve (AUC), which is robust to imbalances in sample size for each mental state by incorporating the relationship between true positive and false positive rates. A higher AUC indicates better classifier performance.

  2 weeks

• Changes in blood oxygen level-dependent (BOLD) signals across the whole brain during different internal thoughts and emotion regulation strategies.

  Differences in whole brain activation patterns, elicited by various internal thoughts and emotion regulation strategies, will be quantified based on changes in blood oxygen level-dependent (BOLD) signals in the whole brain. An increase in BOLD signal indicates a greater brain activation.

  2 weeks

Other Outcomes (7)

• Correlations of Ruminative Responses Scale (RRS) Brooding subscores with classification accuracy and BOLD signal changes

  2 weeks

• Correlations of Ruminative Responses Scale (RRS) Depression subscores with classification accuracy and BOLD signal changes

  2 weeks

• Correlations of Ruminative Responses Scale (RRS) Reflection subscores with classification accuracy and BOLD signal changes

  2 weeks

Interventions

functional magnetic resonance imaging (fMRI) BEHAVIORAL

The investigators will utilize standard BOLD fMRI in blocked-design tasks and resting state (participant is given no overt task) in the study. Anatomical scans with T1-weighted contrast, quantitative measurement of spin relaxation times, and diffusion tensor imaging (DTI) are also used as an anatomical reference for functional activation as well as to investigate a brain structural relationship with the participants' task performance, including successful emotion regulation.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with major depressive disorders

You may qualify if:

• Capable of understanding and complying with protocol requirements.
• Participants who are fluent and literate in English and are able to understand and provide written, informed consent and any required privacy authorization prior to the initiation of any study procedures.
• Male or female, 18 to 65 years.
• Current diagnosis of MDD who are currently depressed defined by the MINI.
• Participants who have moderate depressive symptoms (Patient Health Questionnaire: PHQ-9 ≥ 10 or Quick Inventory of Depressive Symptomatology: QIDS-SR ≥ 11).

You may not qualify if:

• Diagnosis of Schizophrenia spectrum or other psychotic disorders.
• Bipolar I Disorder.
• Active suicidal ideation with a plan and intent or suicidal ideation/attempts in the past 6-12 months.
• Current diagnosis of post-traumatic disorder (PTSD) defined by the MINI.
• Change in the dose or prescription of medication within the 6 weeks before enrolling in the study that could affect brain functioning.
• Moderate to severe substance use disorder within the last 12 months.
• A positive test for drugs of abuse, including but not limited to alcohol (breath test), cocaine, marijuana, opiates, amphetamines.
• Use of \> 400 mg caffeine or nicotine within the past 2 hours. Medical Conditions
• History of unstable liver or renal insufficiency.
• Significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, hematologic, rheumatologic, or metabolic disturbance.
• Moderate to severe traumatic brain injury or neurocognitive disorders with evidence of neurological deficits.
• Co-morbid medical conditions, including cardiovascular (e.g., history of acute coronary events, stroke) and neurological diseases (e.g., Parkinson's, epilepsy).
• Co-morbid inflammatory disorders (e.g., rheumatoid arthritis, autoimmune disorders).
• Uncontrolled or unstable medical conditions deemed risky by investigators.
• Chronic or acute infectious illness (e.g., HIV, SARS-CoV-2).

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 12, 2024
• Study Start: January 10, 2024
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)