Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05169346
Other study ID # 849298
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 25, 2022
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source University of Pennsylvania
Contact Frederick Nitchie
Phone (215) 573-9058
Email frederick.nitchie@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study tests the efficacy of a new psychotherapeutic strategy for reducing negative attention bias (and therefore depression severity) in participants with MDD (60 in R61 phase and 80 in R33 Phase). 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.


Description:

In both the R61and R33 phases we 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


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date December 31, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Active Closed Loop Real Time fMRI Neurofeedback
Active neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)
Sham Closed Loop Real Time fMRI Neurofeedback
Sham (placebo) neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)

Locations

Country Name City State
United States Center for Neuromodulation in Depression and Stress Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attention Mechanism of Depression Associate neurofeedback related changes in our hypothesized attentional mechanism of depression (i.e. neural perseveration of negative states) with changes in depression severity as measured by the Montgomery Asberg Depression Rating Scale (MADRS). 5 years
See also
  Status Clinical Trial Phase
Completed NCT04482296 - Effect of Zinc Supplementation on Depression in SSRI-treated Major Depressive Disorder Patients N/A
Recruiting NCT04071886 - Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study N/A
Completed NCT04076644 - Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder N/A
Completed NCT05528315 - SAD/MAD of ABX-002-1902 Investigating the Safety, Pharmacokinetics/Pharmacodynamics of in Healthy Subjects Phase 1
Recruiting NCT05437588 - Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents N/A
Recruiting NCT06095778 - rTMS Therapy for Treatment-Resistant Depression With Different Targets Guided by pBFS N/A
Active, not recruiting NCT05657691 - Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD) Phase 2
Completed NCT02013609 - Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment Phase 3
Completed NCT02339285 - Transcranial Alternating Current Stimulation for Major Depressive Disorder N/A
Recruiting NCT03971305 - A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL
Completed NCT01344733 - A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD) N/A
Completed NCT04268316 - Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder N/A
Active, not recruiting NCT01557946 - Glutamatergic and GABAergic Mediators of Antidepressant Response in Major Depression Phase 2
Recruiting NCT01501812 - Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders N/A
Completed NCT04880460 - Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients Phase 2
Completed NCT04226352 - Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder Phase 1
Recruiting NCT03754712 - Effect of Vitamin D Administration Along With SSRIs in Patients With Major Depressive Disorder N/A
Recruiting NCT02669030 - A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia Phase 4
Completed NCT03994081 - Mechanism of Action of tACS for the Treatment of MDD N/A
Completed NCT01152554 - A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder Phase 3