N/A
N=36
Effect of Amygdala Neurofeedback on Depressive Symptoms and Processing Biases
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02079610 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks — 23.5; 23.8; 11.9; 21.9 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- real-time fMRI neurofeedback: Amygdala (Behavioral); real-time fMRI neurofeedback: HIPS (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laureate Institute for Brain Research, Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks |
23.5; 23.8; 11.9; 21.9 | <0.001 sig |
| SECONDARY Change From Baseline Beck Depression Inventory at 2 Weeks |
27.2; 26.6; 16.1; 24.3 | 0.03 sig |
| SECONDARY Change From Baseline Hamilton Rating Scale for Depression at 2 Weeks |
19.4; 19.1; 10.4; 17.2 | 0.01 sig |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02079610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.