- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02709161
Effects of Amygdala Neurofeedback on Depressive Symptoms
December 2, 2022 updated by: Kymberly Young, University of Pittsburgh
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Previous research has shown that real-time fMRI neurofeedback (rtfMRI-nf) training aimed at increasing the amygdala's response to positive autobiographical memory recall holds therapeutic potential for treating patients with major depressive disorder (MDD), as clinically significant decreases in clinician administered and self-report measures of depression severity were observed following two rtfMRI amygdala neurofeedback sessions.
Furthermore, rtfMRI amygdala neurofeedback changed emotional processing towards a positive bias.
As this rtfMRI-nf procedure utilizes principles of cognitive-behavioral therapy (CBT), including restructuring thoughts and emotional processing towards the positive, the current study seeks to examine the effects of augmenting CBT with amygdala rtfMRI-nf.
Specifically, the investigators plan to test the hypothesis that pretreatment with two amygdala rtfMRI-nf sessions prior to the the start of CBT will result in a higher percentage of patients who exhibit 'sudden gains' (a between session drop of at least 25% on the Beck Depression Inventory associated with better treatment response) compared to those who receive rtfMRI-nf from a parietal control region putatively not involved in emotional processing.
Over the course of three years, 60 participants diagnosed with MDD and planning to start CBT will be recruited through the clinical services of the Western Psychiatric Institute and Clinic (WPIC) and through licensed CBT therapists in the Pittsburgh metropolitan area.
Participants will undergo two rtfMRI-nf sessions within the two weeks prior to starting therapy.
Half of the participants will receive amygdala neurofeedback and half will receive control neurofeedback.
At weeks 1-3 and 9 & 10 following the start of therapy, the participant will complete the BDI-II and the NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression measure.
The number of patients who meet criteria for sudden gains and the average session at which this occurred will be compared between CBT + amygdala rtfMRI-nf and CBT + control rtfMRI-nf groups.
Success will suggest a new method for improving outcomes to CBT in depressed patients.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
- University of Pittsburgh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: real-time fMRI neurofeedback: Amygdala
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.
|
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
|
Active Comparator: real-time fMRI neurofeedback: HIPS
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Beck Depression Inventory (BDI-II)
Time Frame: 10 weeks
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PROMIS Item Bank v1.0 - Depression
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
March 10, 2016
First Submitted That Met QC Criteria
March 14, 2016
First Posted (Estimate)
March 15, 2016
Study Record Updates
Last Update Posted (Actual)
December 5, 2022
Last Update Submitted That Met QC Criteria
December 2, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO16010381
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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