Depressive Disorder, MajorRNT-decodingNCT06254144
Neuroimaging Study for Decoding Emotional States and Identifying Neural Circuits to Disengage From Negative Thinking
An observational study of Depressive Disorder, Major, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- functional magnetic resonance imaging (fMRI)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to 29 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with major depressive disorders
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 23Show fewer
- 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).
- Current use of hormone-containing medications (excluding contraceptives), immunosuppressive medications, non-steroid anti-inflammatory drugs, or analgesics.
- MRI Contraindications
- Contraindications for MRI (e.g., metal fragments, cardiac pacemaker). Miscellaneous
- Unwillingness or inability to complete any of the major aspects of the study protocol.
- Non-correctable vision or hearing problems.
- Lack of understanding of English.
- BMI > 40 or < 18.5.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
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.
Read the detailed description
This study aims to identify brain activation patterns associated with successful disengagement from negative thinking for MDD-affected participants. The investigators will use a machine learning classifier to decode thinking states from participants' fMRI signals. The decoder is utilized to trace the thinking state's time course as a measure of regulation performance. Investigating the brain activation correlated with the time course of the regulation success can indicate the neural circuits contributing to disengaging from negative thinking. The investigators will also explore the most effective regulation strategy for individual participants. Participants will be instructed to use three regulation strategies: mindfulness by focusing on breathing, distraction with positive thinking, and reinterpretation of a negative thing in a positive way. The investigators expect that the effective strategy could vary across participants, which could be associated with the variability of brain activation patterns in negative thinking.
- Conditions
- Depressive Disorder, Major
- Being tested
- functional magnetic resonance imaging (fMRI)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional magnetic resonance imaging (fMRI)Behavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start10 Jan 2024
- Primary completion29 Dec 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254144
- Sponsor's protocol ID
- 2022-006
- Acronym
- RNT-decoding
- Status last verified
- Apr 2026
- First submitted
- 26 Jan 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Study for Decoding Emotional States and Identifying Neural Circuits to Disengage From Negative Thinking
- ClinicalTrials.gov ID
- NCT06254144
- Acronym / sponsor ID
- RNT-decoding / 2022-006
- Conditions
- Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to identify brain activation patterns associated with successful disengagement from negative thinking for MDD-affected participants. The investigators will use a machine learning classifier to decode thinking states from participants' fMRI signals. The decoder is utilized to trace the thinking state's time course as a measure of regulation performance. Investigating the brain activation correlated with the time course of the regulation success can indicate the neural circuits contributing to disengaging from negative thinking. The investigators will also explore the most effective regulation strategy for individual participants. Participants will be instructed to use three regulation strategies: mindfulness by focusing on breathing, distraction with positive thinking, and reinterpretation of a negative thing in a positive way. The investigators expect that the effective strategy could vary across participants, which could be associated with the variability of brain activation patterns in negative thinking.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with major depressive disorders
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional magnetic resonance imaging (fMRI)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. | Behavioural | – |
Primary outcome
Classification accuracy of different internal thoughts
Time frame: 2 weeks
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.
Changes in blood oxygen level-dependent (BOLD) signals across the whole brain during different internal thoughts and emotion regulation strategies.
Time frame: 2 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification accuracy of different internal thoughts (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.