Major Depressive Disorder (MDD)
Conditions
Brief summary
This study tests the efficacy of a new psychotherapeutic strategy for reducing negative attention bias (and therefore depression severity) in participants with MDD. This real-time fMRI neurofeedback therapy uses cloud-based pattern classification to decode a patient's attentional state and dynamically modulate task stimuli (in a closed loop) based on this state.
Detailed description
The investigators will compare cloud based real time fMRI feedback with placebo (sham feedback) in reducing negative attention bias and depressive symptoms. This study will be the first dose-finding test of real-time fMRI effect on negative attention bias. Measures include: Structured Clinical Interview for DSM-5 (SCID), Clinician-administered diagnostic exam, Montgomery Asberg Depression Rating Scale (MADRS), Clinician-administered scale used to assess the severity of depression, State-Trait Anxiety Inventory (STAI), Self-report questionnaire used to measure types of anxiety and mood symptoms, Mood and Anxiety Symptom Questionnaire (MASQ), Negative perseveration during a go/no-go task, Go/no-go task with overlaid face/scene stimuli; brain response triggers next stimulus, Negative gaze, Negative gaze collected in gaze data following each real time fMRI feedback session
Interventions
Active neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)
Sham (placebo) neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Gender, inclusive * Adult aged 18 - 65 * Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for MDD according to the Clinician-Administered MDD Scale for DSM-5 (unipolar depression or bipolar II depressed) * Scores at least a minimum score of 16 on Montgomery Asberg Depression Rating Scale (MADRS) * Normal cognition * Participants must be able to read and understand English * Participants must be able to provide consent
Exclusion criteria
* Pregnancy (female participants) * Outside age range * MRI contraindications (medical implant, claustrophobia, etc.) * Use of psychoactive medication (including antidepressants) or currently in therapy * Neurological disorder or any condition that in the view of the PI could impact brain data, cause depression, require medication that could cause depressive symptoms, or otherwise result in participant being unfit for study (for example, co-morbid psychotic, neurological disorders, developmentally or cognitively disabled/impaired, active alcohol or drug abuse/dependence within the past 6 months). * Non-English speaking * Non-correctable vision loss * Refusal to provide informed consent * representing an active suicide risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) | 3 months | Clinician administered scale to assess the severity of depression. MADRS scores will be compare the effect of real-time neurofeedback vs sham neurofeedback on depression outcome in patients with MDD. A MADRS score of 16 or higher is needed in order to be eligible to be enrolled in the study. The higher the MADRS score, the more depressed the individual will be. A lower MADRS score indicates that the individual's depressive symptoms have improved. A higher MADRS score indicates that the individual's depressive symptoms have worsened. |
Countries
United States
Contacts
Primary ContactYvette Sheline, M.D.
Outcome results
None listed