Major Depressive Disorder Clinical Trial
Official title:
Effect of Amygdala Neurofeedback on Depressive Symptoms and Processing Biases
Verified date | July 2017 |
Source | Laureate Institute for Brain Research, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Laureate Institute for Brain Research | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Laureate Institute for Brain Research, Inc. | National Institute of Mental Health (NIMH) |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change From Baseline Beck Depression Inventory at 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 |
baseline and 2 weeks | |
Secondary | Change From Baseline Hamilton Rating Scale for Depression at 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 |
baseline and 2 weeks |
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