Major Depressive DisorderGUIMRINFB1NCT01920490
Blame Rebalance fMRI Feedback Proof-of-concept
A study testing GUILT-INCREASE-CORRELATION and GUILT-STABILIZE-CORRELATION in people with Major Depressive Disorder, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial summary
The investigators have shown that decoupling of brain networks when feeling guilty is the first potential functional neuroimaging biomarker of risk of major depression. It remains detectable on remission of symptoms (Green et al., 2012). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- GUILT-INCREASE-CORRELATION and GUILT-STABILIZE-CORRELATION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Oct 2014
- Phase
- Interventional
- 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
Who may be able to join
- past major depressive episode according to Diagnostic Statistical Manual (DSMIV) for at least 2 months, currently not fulfilling criteria for depression and remitted from symptoms for at least 2 months
Who cannot join
- suicidal thoughts
- other current DSM-IV axis-I disorders
- a history of atypical major depressive episodes (DSM-IV)
- Global Assessment of Functioning scores below 80 as a sign of incomplete remission or co-morbidity
- >2 points on the suicidality item of the Hamilton Depression Scale
- prior criminal convictions
Show all 11Show fewer
- history of violent behavior towards persons as determined by clinical interview
- positive past or current screening question for irritability on the mood disorders module
- antisocial personality as determined on personality interview using DSM-IV criteria
- borderline personality disorder as determined on personality interview using DSM-IV criteria according to the personality interview
- current self-harming behaviors
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 22290-140
About this study
Official title: Rebalancing Blame Using fMRI Neurofeedback: a Double-blind Controlled Clinical Proof-of-concept Trial in Remitted Major Depressive Disorder
The investigators have shown that decoupling of brain networks when feeling guilty is the first potential functional neuroimaging biomarker of risk of major depression. It remains detectable on remission of symptoms (Green et al., 2012). Decoupling of neural networks was found while people felt guilty during functional magnetic resonance imaging (fMRI) relative to feeling indignation. Guilt-selective brain decoupling is therefore an excellent target for interventions to reduce the largely increased risk of recurrent episodes in people who have had one episode but are currently remitted. To our knowledge, however, there is no proof-of-concept study showing that self-blame-selective decoupling on fMRI can be detected and fed back to the participants after a short temporal delay in a real-time fMRI setting and whether coupling can be increased through neurofeedback training. This project aims at developing the first fMRI neurofeedback system to treat self-blame-selective neural decoupling and to test its feasibility in people with major depressive disorder currently remitted from symptoms.
Read the detailed description
Specific aim 1: Demonstrate that anterior temporal lobe (ATL)-septal/subgenual cingulate (SCSR) coupling for guilt can be increased through one session of neurofeedback in the group seeing visual feedback based on increasing correlations during the guilt condition compared with the group seeing visual feedback based on keeping correlations at the same level during the guilt condition.
Specific aim 2: Demonstrate that this increase in coupling is selective for guilt relative to indignation.
Specific aim 3: Demonstrate that mood is not negatively affected by neurofeedback.
Specific aim 4: Explore whether this short intervention decreases self-hate on the Interpersonal Guilt Questionnaire (Portuguese translation) and increases self-esteem on the Rosenberg scale (both show significant correlations with SCSR-ATL coupling across major depressive disorder and control groups in our Manchester study), or if these measures are not available, decreases negative affect on the Positive and Negative Affect Scale.
- Conditions
- Major Depressive Disorder
- Being tested
- GUILT-INCREASE-CORRELATION, GUILT-STABILIZE-CORRELATION
- 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.
GUILT-INCREASE-CORRELATIONDevice
This uses a novel software "FRIEND" created at IDOR in Rio de Janeiro, Brazil. The software is used on a regular clinical fMRI scanner
GUILT-STABILIZE-CORRELATIONDevice
This uses a novel software "FRIEND" created at IDOR in Rio de Janeiro, Brazil. The software is used on a regular clinical fMRI scanner
| Study group | Role | What they receive |
|---|---|---|
| GUILT-INCREASE-CORRELATION | Experimental | Patients in this group will receive visual feedback that reinforces increasing the correlation in fMRI signal between the right superior anterior temporal and septal-subgenual regions during the retrieval of predefined guilt-related autobiographical episodes. During the indignation condition, visual feedback will reinforce stabilization of the preceding degree of correlation. Receives: Device: GUILT-INCREASE-CORRELATION |
| GUILT-STABILIZE-CORRELATION | Active comparator | Patients in this group will receive visual feedback that reinforces stabilization of the preceding degree of correlation in fMRI signal between the right superior anterior temporal and septal-subgenual regions during the retrieval of predefined guilt-related autobiographical episodes. During the indignation condition, visual feedback will also reinforce stabilization of the preceding degree of correlation. Receives: Device: GUILT-STABILIZE-CORRELATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in correlation between anterior temporal and subgenual frontal fMRI signal for guilt relative to indignation
Correlations are computed by using average signal in the most highly activated voxels within a priori regions of interest in the right superior anterior temporal and septal/subgenual cingulate region. The same a priori regions are also used to provide neurofeedback.
Measured: change from baseline after one session of fMRI neurofeedback training
Secondary outcomes (3)
Beck Depression Inventory
This is an outcome measure to ensure the safety of our intervention, we expect that one session of fMRI neurofeedback will not lead to a significant increase in Beck Depression Inventory scores when comparing scores after and before the training session.
Measured: Change from baseline after one session of fMRI neurofeedback training
Interpersonal Guilt Questionnaire - Self-hate subscale
This is an exploratory outcome measure to determine whether there is a detectable effect on self-blaming emotions after one session of fMRI neurofeedback. This is not our primary aim in that this study is primarily designed to determine feasibility and safety rather than efficacy.
Measured: Change from baseline after one session of fMRI neurofeedback training
Rosenberg Self-Esteem Scale
This is an exploratory outcome measure to determine whether there is a detectable effect on global self-esteem after one session of fMRI neurofeedback. This is not our primary aim in that this study is primarily designed to determine feasibility and safety rather than efficacy.
Measured: Change from baseline after one session of fMRI neurofeedback
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Moll, MD PhD, Study director, D'Or Institute for Research and EducationRoland Zahn, MD PhD, Principal investigator, D'Or Institute for Research and EducationPaulo Mattos, MD PhD, Principal investigator, D'Or Institute for Research and EducationRicardo de Oliveira-Souza, MD PhD, Principal investigator, D'Or Institute for Research and EducationLeonardo F Fontenelle, M.D., Principal investigator, Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920490
- Sponsor's protocol ID
- IDOR
- Acronym
- GUIMRINFB1
- Status last verified
- Jul 2015
- First submitted
- 22 Apr 2013
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Green S, Lambon Ralph MA, Moll J, Deakin JF, Zahn R. Guilt-selective functional disconnection of anterior temporal and subgenual cortices in major depressive disorder. Arch Gen Psychiatry. 2012 Oct;69(10):1014-21. doi: 10.1001/archgenpsychiatry.2012.135.
PubMed 22638494Zahn R, Weingartner JH, Basilio R, Bado P, Mattos P, Sato JR, de Oliveira-Souza R, Fontenelle LF, Young AH, Moll J. Blame-rebalance fMRI neurofeedback in major depressive disorder: A randomised proof-of-concept trial. Neuroimage Clin. 2019;24:101992. doi: 10.1016/j.nicl.2019.101992. Epub 2019 Aug 25.
PubMed 31505367
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebalancing Blame Using fMRI Neurofeedback: a Double-blind Controlled Clinical Proof-of-concept Trial in Remitted Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01920490
- Acronym / sponsor ID
- GUIMRINFB1 / IDOR
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Aug 2013 (estimated)
- 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 investigators have shown that decoupling of brain networks when feeling guilty is the first potential functional neuroimaging biomarker of risk of major depression. It remains detectable on remission of symptoms (Green et al., 2012). Decoupling of neural networks was found while people felt guilty during functional magnetic resonance imaging (fMRI) relative to feeling indignation. Guilt-selective brain decoupling is therefore an excellent target for interventions to reduce the largely increased risk of recurrent episodes in people who have had one episode but are currently remitted. To our knowledge, however, there is no proof-of-concept study showing that self-blame-selective decoupling on fMRI can be detected and fed back to the participants after a short temporal delay in a real-time fMRI setting and whether coupling can be increased through neurofeedback training. This project aims at developing the first fMRI neurofeedback system to treat self-blame-selective neural decoupling and to test its feasibility in people with major depressive disorder currently remitted from symptoms.
Detailed description
Specific aim 1: Demonstrate that anterior temporal lobe (ATL)-septal/subgenual cingulate (SCSR) coupling for guilt can be increased through one session of neurofeedback in the group seeing visual feedback based on increasing correlations during the guilt condition compared with the group seeing visual feedback based on keeping correlations at the same level during the guilt condition.
Specific aim 2: Demonstrate that this increase in coupling is selective for guilt relative to indignation.
Specific aim 3: Demonstrate that mood is not negatively affected by neurofeedback.
Specific aim 4: Explore whether this short intervention decreases self-hate on the Interpersonal Guilt Questionnaire (Portuguese translation) and increases self-esteem on the Rosenberg scale (both show significant correlations with SCSR-ATL coupling across major depressive disorder and control groups in our Manchester study), or if these measures are not available, decreases negative affect on the Positive and Negative Affect Scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GUILT-INCREASE-CORRELATION | Experimental | Device: GUILT-INCREASE-CORRELATIONPatients in this group will receive visual feedback that reinforces increasing the correlation in fMRI signal between the right superior anterior temporal and septal-subgenual regions during the retrieval of predefined guilt-related autobiographical episodes. During the indignation condition, visual feedback will reinforce stabilization of the preceding degree of correlation. |
| GUILT-STABILIZE-CORRELATION | Active comparator | Device: GUILT-STABILIZE-CORRELATIONPatients in this group will receive visual feedback that reinforces stabilization of the preceding degree of correlation in fMRI signal between the right superior anterior temporal and septal-subgenual regions during the retrieval of predefined guilt-related autobiographical episodes. During the indignation condition, visual feedback will also reinforce stabilization of the preceding degree of correlation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- past major depressive episode according to Diagnostic Statistical Manual (DSMIV) for at least 2 months, currently not fulfilling criteria for depression and remitted from symptoms for at least 2 months
Key exclusion criteria (11 listed)
- suicidal thoughts
- other current DSM-IV axis-I disorders
- a history of atypical major depressive episodes (DSM-IV)
- Global Assessment of Functioning scores below 80 as a sign of incomplete remission or co-morbidity
- >2 points on the suicidality item of the Hamilton Depression Scale
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 |
|---|---|---|
| GUILT-INCREASE-CORRELATIONThis uses a novel software "FRIEND" created at IDOR in Rio de Janeiro, Brazil. The software is used on a regular clinical fMRI scanner | Device | GUILT-INCREASE-CORRELATION |
| GUILT-STABILIZE-CORRELATIONThis uses a novel software "FRIEND" created at IDOR in Rio de Janeiro, Brazil. The software is used on a regular clinical fMRI scanner | Device | GUILT-STABILIZE-CORRELATION |
Primary outcome
Increase in correlation between anterior temporal and subgenual frontal fMRI signal for guilt relative to indignation
Time frame: change from baseline after one session of fMRI neurofeedback training
Correlations are computed by using average signal in the most highly activated voxels within a priori regions of interest in the right superior anterior temporal and septal/subgenual cingulate region. The same a priori regions are also used to provide neurofeedback.
3 secondary outcomes
Beck Depression Inventory
Time frame: Change from baseline after one session of fMRI neurofeedback training
Interpersonal Guilt Questionnaire - Self-hate subscale
Time frame: Change from baseline after one session of fMRI neurofeedback training
Rosenberg Self-Esteem Scale
Time frame: Change from baseline after one session of fMRI neurofeedback
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 Jul 2015.
- Background: PubMed 22638494Green S, Lambon Ralph MA, Moll J, Deakin JF, Zahn R. Guilt-selective functional disconnection of anterior temporal and subgenual cortices in major depressive disorder. Arch Gen Psychiatry. 2012 Oct;69(10):1014-21. doi: 10.1001/archgenpsychiatry.2012.135.
- Derived from this study: PubMed 31505367Zahn R, Weingartner JH, Basilio R, Bado P, Mattos P, Sato JR, de Oliveira-Souza R, Fontenelle LF, Young AH, Moll J. Blame-rebalance fMRI neurofeedback in major depressive disorder: A randomised proof-of-concept trial. Neuroimage Clin. 2019;24:101992. doi: 10.1016/j.nicl.2019.101992. Epub 2019 Aug 25.
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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.
Jorge Moll, MD PhD study director
D'Or Institute for Research and Education
Roland Zahn, MD PhD principal investigator
D'Or Institute for Research and Education
Paulo Mattos, MD PhD principal investigator
D'Or Institute for Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GUILT-INCREASE-CORRELATION and GUILT-STABILIZE-CORRELATION in people with Major Depressive Disorder, run by D'Or Institute for Research and Education at 1 site in Brazil.
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 1 inclusion and 11 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 Jul 2015. 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 Brazil. 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?
Increase in correlation between anterior temporal and subgenual frontal fMRI signal for guilt relative to indignation (time frame: change from baseline after one session of fMRI neurofeedback training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920490, which also lists 2 linked publications.
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 Jul 2015.