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Neurofeedback for Treatment Resistant Depression

Primary Purpose

Treatment Resistant Depression

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Amygdala Neurofeedback

Parietal Neurofeedback

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring Neurofeedback, major depressive disorder, treatment resistant, amygdala

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

right-handed adults (ages 18 - 55) with a primary diagnosis of MDD according to diagnostic criteria DSM-5 for recurrent MDD who are currently depressed will be recruited to participate
must be able to give written informed consent prior to participation
must have fewer than 45% memories categorized as specific on the Autobiographical Memory Test
must have a SHAPS score > 4, indicating the presence of anhedonia
unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable)
previously failed to respond to two previous SSRI medications according to either a medical record review or clinical interview during Visit 1

Exclusion Criteria:

have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
met DSM-IV criteria for alcohol and/or substance dependence (other than nicotine) within 12 months prior to screening
have a history of traumatic brain injury
are unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
are currently pregnant or breast feeding
are 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 SSRI antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. Inclusion of patients on stable antidepressant medications was decided in order to allow generalization towards a real world population
have a DSM-5 diagnosis of psychotic or organic mental disorder, bipolar I or II disorder or any past or current manic or hypomanic symptoms, autism, or a primary diagnosis of an anxiety disorder (though co-morbid anxiety will not be excluded)
have any eye problems or difficulties in corrected vision.

Sites / Locations

University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amygdala Neurofeedback

Parietal Neurofeedback

Arm Description

attempt to up regulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Five sessions will be performed within a 2 month period.

attempt to upregulate the left horizontal segment of the intraparietal sulcus, a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback. Five sessions will be performed within a 2 month period.

Outcomes

Primary Outcome Measures

Beck Depression Inventory (BDI-II)

Secondary Outcome Measures

Amygdala Activity

% signal change from initial baseline to final transfer run in amygdala activity during ftMRI-nf sessions

Full Information

NCT ID

NCT03428828

First Posted

February 1, 2018

Last Updated

March 8, 2023

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT03428828

Brief Title

Neurofeedback for Treatment Resistant Depression

Official Title

Amygdala rtfMRI Neurofeedback for Treatment Resistant Depression

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 22, 2018 (Actual)

Primary Completion Date

March 1, 2025 (Anticipated)

Study Completion Date

March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the clinical efficacy of real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive autobiographical memories in patients with depression who are considered treatment-resistant

Detailed Description

Up to two-thirds of patients diagnosed with major depressive disorder (MDD) will not respond to standard pharmacological and psychological interventions and will be considered treatment resistant (TR-MDD). Decreased reactivity to positive stimuli, indexed by low amygdala reactivity to positive autobiographical memory recall, may be a causal mechanism interfering with recovery from TR-MDD. Previous work in our lab suggests that individuals who do respond to antidepressant medications show increased amygdala activity that is indistinguishable from controls relative to baseline, while TR-MDD individuals fail to show this increase in amygdala activity. Furthermore, the investigators have found that MDD participants (more generally, not specifically TR- MDD) are indeed able to increase their amygdala response during positive memory recall via real-time fMRI neurofeedback (rtfMRI-nf) training, and that this increase is associated with large and rapid reductions in depressive symptoms. Here, the investigators propose to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as an intervention for TR-MDD. 100 TR-MDD individuals will be randomly assigned under double-blind conditions to receive 5 amygdala rtfMRI-nf or 5 control rtfMRI-nf sessions where they are trained to regulate a parietal region putatively not involved in emotional processing or MDD. The investigators will assess changes in amygdala activity, severity of clinical symptoms, and autobiographical memory deficits. Success will suggest a new non- pharmacological, non-invasive intervention for a traditionally treatment-resistant population of MDD individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment Resistant Depression

Keywords

Neurofeedback, major depressive disorder, treatment resistant, amygdala

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Amygdala Neurofeedback

Arm Type

Experimental

Arm Description

attempt to up regulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Five sessions will be performed within a 2 month period.

Arm Title

Parietal Neurofeedback

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Amygdala Neurofeedback

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Parietal Neurofeedback

Intervention Description

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

Primary Outcome Measure Information:

Title

Beck Depression Inventory (BDI-II)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Amygdala Activity

Description

% signal change from initial baseline to final transfer run in amygdala activity during ftMRI-nf sessions

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: right-handed adults (ages 18 - 55) with a primary diagnosis of MDD according to diagnostic criteria DSM-5 for recurrent MDD who are currently depressed will be recruited to participate must be able to give written informed consent prior to participation must have fewer than 45% memories categorized as specific on the Autobiographical Memory Test must have a SHAPS score > 4, indicating the presence of anhedonia unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable) previously failed to respond to two previous SSRI medications according to either a medical record review or clinical interview during Visit 1 Exclusion Criteria: have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder met DSM-IV criteria for alcohol and/or substance dependence (other than nicotine) within 12 months prior to screening have a history of traumatic brain injury are unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body) are currently pregnant or breast feeding are 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 SSRI antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. Inclusion of patients on stable antidepressant medications was decided in order to allow generalization towards a real world population have a DSM-5 diagnosis of psychotic or organic mental disorder, bipolar I or II disorder or any past or current manic or hypomanic symptoms, autism, or a primary diagnosis of an anxiety disorder (though co-morbid anxiety will not be excluded) have any eye problems or difficulties in corrected vision.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Scott Barb

Phone

412-648-6809

barbsm3@upmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kymberly Young, PhD

Phone

412-648-6179

youngk@pitt.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kymberly Young, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15261

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kymberly Young, PhD

youngk@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The final data set will include self-reported demographic and behavioral data, clinical-rated information regarding illness course, severity, and comorbidities, and brain-imaging data collected during fMRI. The dataset will be stripped of identifiers prior to release for sharing, and will be shared openly and timely in accordance with the most recent NIH guidelines. Data will be shared every six months on the NIH-supported National Database for Clinical Trials Related to Mental Illness (NDCT) data repository.

Citations:

PubMed Identifier

28407727

Citation

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.

Results Reference

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Neurofeedback for Treatment Resistant Depression

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