Study Stopped
The grant funding ran out
Effects of Amygdala Neurofeedback on Depressive Symptoms
2 other identifiers
interventional
36
1 country
1
Brief Summary
The purpose of this study is to determine the clinical efficacy of augmenting cognitive-behavioral therapy with real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive autobiographical memories.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Oct 2016
Typical duration for not_applicable major-depressive-disorder
1 active site
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 10, 2016
CompletedFirst Posted
Study publicly available on registry
March 15, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedResults Posted
Study results publicly available
December 27, 2024
CompletedDecember 27, 2024
December 1, 2024
3.5 years
March 10, 2016
November 12, 2024
December 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Beck Depression Inventory (BDI-II)
The Beck Depression Inventory is a self-report questionnaire consisting of 21 questions assessing depressive symptoms. Scores can range from 0-63 with higher scores indicating more severe depression.
10 weeks
Secondary Outcomes (1)
PROMIS Item Bank v1.0 - Depression
10 weeks
Study Arms (2)
real-time fMRI neurofeedback: Amygdala
EXPERIMENTALAmygdala 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.
real-time fMRI neurofeedback: HIPS
ACTIVE COMPARATORHIPS 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.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- right-handed adults
- ages 18 - 55
- primary diagnosis of MDD for recurrent MDD who are currently depressed
- able to give written informed consent prior to participation
- unmedicated OR are stable on an unsuccessful antidepressant regime (at least 4 weeks to ensure symptoms are stable). Effective medications will not be discontinued for the purposes of the study.
You may not qualify if:
- clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
- alcohol and/or substance dependence (other than nicotine) within 12 months prior to screening
- history of traumatic brain injury
- currently pregnant or breast feeding
- unable to complete questionnaires written in English
- current (within 3 weeks of testing) use of any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications (except antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. I
- diagnosis of psychotic or organic mental disorder, bipolar I or II disorder.
- eye problems or difficulties in corrected vision.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kymberly Younglead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Related Publications (1)
Compere L, Siegle GJ, Lazzaro S, Strege M, Canovali G, Barb S, Huppert T, Young K. Real-time functional magnetic resonance imaging neurofeedback training of amygdala upregulation increases affective flexibility in depression. J Psychiatry Neurosci. 2023 Jun 20;48(3):E232-E239. doi: 10.1503/jpn.220208. Print 2023 May-Jun.
PMID: 37339817DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kymberly Young
- Organization
- University of Pittsburgh
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 INVESTIGATOR
- PI Title
- Assistant Professor of Psychiatry
Study Record Dates
First Submitted
March 10, 2016
First Posted
March 15, 2016
Study Start
October 1, 2016
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
December 27, 2024
Results First Posted
December 27, 2024
Record last verified: 2024-12