Blame Rebalance fMRI Feedback Proof-of-concept

Major Depressive Disorder Clinical Trial

— GUIMRINFB1  

Official title:

Rebalancing Blame Using fMRI Neurofeedback: a Double-blind Controlled Clinical Proof-of-concept Trial in Remitted Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920490
• Other study ID #: IDOR
• Status: Completed
• Phase: N/A
• First received: April 22, 2013
• Last updated: July 21, 2015
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: July 2015
• Source: D'Or Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• GUILT-INCREASE-CORRELATION
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-CORRELATION
This uses a novel software "FRIEND" created at IDOR in Rio de Janeiro, Brazil. The software is used on a regular clinical fMRI scanner

Locations

Country	Name	City	State
Brazil	Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change from baseline after one session of fMRI neurofeedback training	No
Secondary	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.	Change from baseline after one session of fMRI neurofeedback training	Yes
Secondary	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.	Change from baseline after one session of fMRI neurofeedback training	No
Secondary	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.	Change from baseline after one session of fMRI neurofeedback	No