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Effect of Amygdala Neurofeedback on Depressive Symptoms and Processing Biases

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ClinicalTrials.gov Identifier: NCT02079610
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc.

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: real-time fMRI neurofeedback: Amygdala Behavioral: real-time fMRI neurofeedback: HIPS Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Amygdala Neurofeedback on Depressive Symptoms and Processing Biases
Study Start Date : April 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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.
Behavioral: real-time fMRI neurofeedback: Amygdala
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.
Behavioral: real-time fMRI neurofeedback: HIPS
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 Measures :
  1. Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks [ Time Frame: baseline and 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



Secondary Outcome Measures :
  1. Change From Baseline Beck Depression Inventory at 2 Weeks [ Time Frame: baseline and 2 weeks ]

    Depression symptom severity rating scale. The overall score ranges on BDI are from from 0 to 63, with higher scores indicating more severe depression. Usual cutoff points are:

    0 to 13 - normal /symptom absent 14 to 19 - mild depression 20 to 28 - moderate depression >29 - severe depression


  2. Change From Baseline Hamilton Rating Scale for Depression at 2 Weeks [ Time Frame: baseline and 2 weeks ]

    Depression symptom severity rating scale. The overall score ranges on HDRS are from from 0 to 50, with higher scores indicating more severe depression. Usual cutoff points are:

    0 to 7 - normal /symptom absent 8 to 16 - mild depression 17 to 23 - moderate depression >24 - severe depression




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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • inability to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079610


Locations
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United States, Oklahoma
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136
Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Kymberly D Young, PhD Laureate Institute for Brain Research

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier: NCT02079610     History of Changes
Other Study ID Numbers: 2013-013-00
4R00MH101235-03 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2014    Key Record Dates
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: July 2017
Keywords provided by Laureate Institute for Brain Research, Inc.:
Depression
Neurofeedback
Amygdala
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms