NCT01920490

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

April 22, 2013

Last Update Submit

July 21, 2015

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Beck Depression Inventory

    Change from baseline after one session of fMRI neurofeedback training

  • Interpersonal Guilt Questionnaire - Self-hate subscale

    Change from baseline after one session of fMRI neurofeedback training

  • Rosenberg Self-Esteem Scale

    Change from baseline after one session of fMRI neurofeedback

Study Arms (2)

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.

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.

Device: GUILT-STABILIZE-CORRELATION

Interventions

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-INCREASE-CORRELATION
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

GUILT-STABILIZE-CORRELATION

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 22290-140, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 22638494BACKGROUND

  • Zahn 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.

    PMID: 31505367DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Jorge Moll, MD PhD

    D'Or Institute for Research and Education

    STUDY DIRECTOR

  • Roland Zahn, MD PhD

    D'Or Institute for Research and Education

    PRINCIPAL INVESTIGATOR

  • Paulo Mattos, MD PhD

    D'Or Institute for Research and Education

    PRINCIPAL INVESTIGATOR

  • Ricardo de Oliveira-Souza, MD PhD

    D'Or Institute for Research and Education

    PRINCIPAL INVESTIGATOR

  • Leonardo F Fontenelle, M.D.

    Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2013

First Posted

August 12, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

BR(1)