NCT02079610

Brief Summary

The purpose of this study is to determine whether upregulating the left amygdala during positive autobiographical memory recall via real time functional magnetic resonance imaging neurofeedback will lead to an improvement in clinician administered ratings of depressive symptoms. The investigators predict that patients with major depressive disorder receiving left amygdala neurofeedback will increase their amygdala response during positive autobiographical memory recall compared to those receiving control feedback from a region not involved in emotional processing and that this ability will be associated with clinically significant improvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

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

Timeline
Completed

Started Apr 2014

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

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 25, 2017

Completed
Last Updated

September 25, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

March 4, 2014

Results QC Date

April 24, 2017

Last Update Submit

July 21, 2017

Conditions

Major Depressive Disorder

Keywords

DepressionNeurofeedbackAmygdala

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks

    Depression symptom severity rating scale. The overall score ranges on MADRS are from from 0 to 60, with higher scores indicating more severe depression. Usual cutoff points are: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression

    baseline and 2 weeks

Secondary Outcomes (2)

  • Change From Baseline Beck Depression Inventory at 2 Weeks

    baseline and 2 weeks

  • Change From Baseline Hamilton Rating Scale for Depression at 2 Weeks

    baseline and 2 weeks

Study Arms (2)

real-time fMRI neurofeedback: Amygdala

EXPERIMENTAL

Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.

Behavioral: real-time fMRI neurofeedback: Amygdala

real-time fMRI neurofeedback: HIPS

ACTIVE COMPARATOR

HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.

Behavioral: real-time fMRI neurofeedback: HIPS

Interventions

real-time fMRI neurofeedback: AmygdalaBEHAVIORAL

Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.

real-time fMRI neurofeedback: Amygdala
real-time fMRI neurofeedback: HIPSBEHAVIORAL

Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.

real-time fMRI neurofeedback: HIPS

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • clinical diagnosis of major depressive disorder
  • right handed
  • adult aged 18-55
  • currently depressed

You may not qualify if:

  • clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
  • met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for alcohol and/or substance abuse or substance dependence (other than nicotine) within 12 months prior to screening
  • endorse suicidal intent or have made a suicide attempt within the preceding three months
  • history of traumatic brain injury
  • current pregnancy or breast feeding
  • a primary language other than English
  • received psychotropic drugs for at least 3 weeks (8 weeks for fluoxetine) prior to scanning (Effective medications will not be discontinued for the purposes of the study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Related Publications (4)

  • Zotev V, Phillips R, Young KD, Drevets WC, Bodurka J. Prefrontal control of the amygdala during real-time fMRI neurofeedback training of emotion regulation. PLoS One. 2013 Nov 6;8(11):e79184. doi: 10.1371/journal.pone.0079184. eCollection 2013.

    PMID: 24223175BACKGROUND

  • Zotev V, Krueger F, Phillips R, Alvarez RP, Simmons WK, Bellgowan P, Drevets WC, Bodurka J. Self-regulation of amygdala activation using real-time FMRI neurofeedback. PLoS One. 2011;6(9):e24522. doi: 10.1371/journal.pone.0024522. Epub 2011 Sep 8.

    PMID: 21931738BACKGROUND

  • Young KD, Zotev V, Phillips R, Misaki M, Yuan H, Drevets WC, Bodurka J. Real-time FMRI neurofeedback training of amygdala activity in patients with major depressive disorder. PLoS One. 2014 Feb 11;9(2):e88785. doi: 10.1371/journal.pone.0088785. eCollection 2014.

    PMID: 24523939BACKGROUND

  • Young KD, Siegle GJ, Zotev V, Phillips R, Misaki M, Yuan H, Drevets WC, Bodurka J. Randomized Clinical Trial of Real-Time fMRI Amygdala Neurofeedback for Major Depressive Disorder: Effects on Symptoms and Autobiographical Memory Recall. Am J Psychiatry. 2017 Aug 1;174(8):748-755. doi: 10.1176/appi.ajp.2017.16060637. Epub 2017 Apr 14.

    PMID: 28407727DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Limitations and Caveats

large proportion of patients excluded primarily because of medication status or not meeting DSM-IV-TR criteria for major depressive disorder, limiting the generalizability Patients were only followed for 1 week after the final rtfMRI-nf session

Results Point of Contact

Title
Kymberly Young, PhD
Organization
University of Pittsburgh School of Medicine
youngk@pitt.edu
412-648-6179

Study Officials

  • Kymberly D Young, PhD

    Laureate Institute for Brain Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 25, 2017

Results First Posted

September 25, 2017

Record last verified: 2017-07

Locations

US(1)