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Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics

Primary Purpose

Major Depressive Disorder, Apathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Cognitive Training Intervention
General Cognitive Training Intervention
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 60+ years Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Structured Clinical Interview for DSM-5 (SCID) Montgomery-Åsberg Depression Rating Scale (MADRS) score > or = 16. Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES > or = to 37) Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 5 weeks. On a stable dose of other psychotropic medications, deemed by the investigator to be associated with brain networks of interest, for at least 8 weeks. Capacity to provide written consent for research assessment and treatment Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff. DRS total score > 129 or DRS scaled score of 5 based on age and education-adjusted normative data49 Eligible to undergo MRI Access to a computer or tablet with Wifi capabilities Able to comply with all testing and study requirements and willingness to participate in the full study duration. Exclusion Criteria: History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, persistent depressive disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia Use of cholinesterase inhibitors or psychoactive drugs other than antidepressants or benzodiazepines, including antipsychotics, that in the opinion of the Investigator may confound study data/assessments. Presence or history of significant neurologic or neurodegenerative disorder (e.g., Alzheimer's disease and other dementias, amnestic Mild Cognitive Impairment, history of stroke, Multiple Sclerosis, Parkinson's disease, epilepsy). Any other acute medical condition (e.g., cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses) that may influence brain systems of interest or interfere with participation or interpretation of the study results. Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior. Electroconvulsive therapy within the past 12 months Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder. Participant is currently enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is enrolled in psychotherapy, this will not be grounds for exclusion) Claustrophobia Color Blindness Sensory or physical impairment that would preclude cognitive testing or participation in the intervention (e.g., upper limb paralysis) as reported by the participant or observed by the Investigator. Travelling consecutively for 2+ weeks during the study period to a location that will preclude timely collection of post-treatment MRI data. Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, cochlear implant, any other metallic biomedical implant contraindicating to MRI.

Sites / Locations

  • Lauren Elizabeth Oberlin
  • Weill Cornell Medicine Institute of Geriatric Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Targeted Cognitive Training Intervention

General Cognitive Training Intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks
Calculated from resting state fMRI scan. Validation of target engagement.

Secondary Outcome Measures

Change in Apathy Evaluation Scale (AES) score
The 18-item clinician-rated version of the Apathy Evaluation Scale (AES) will be used to measure apathy severity. Scores range from 18 (no apathy) to 72 (severe apathy).
Change in Stroop Interference score
Stroop interference will be calculated from the computerized Stroop Task to measure cognitive control.

Full Information

First Posted
May 17, 2023
Last Updated
August 21, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05877885
Brief Title
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Official Title
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
February 2028 (Anticipated)
Study Completion Date
March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this randomized controlled trial is to evaluate the potential of a customized digital cognitive training intervention to target aspects of brain function in apathy of late-life depression and reduce symptoms of apathy and related cognitive and behavioral deficits. The investigators hypothesize that 4 weeks of a customized digital cognitive training program will lead to changes in brain connectivity, apathy severity, and cognitive control performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Apathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Targeted Cognitive Training Intervention
Arm Type
Experimental
Arm Title
General Cognitive Training Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Targeted Cognitive Training Intervention
Intervention Description
In this intervention, participants will complete 25-30 minutes of cognitive training per day, 5 days/week (but up to 7 days/week) for 4 weeks. The training protocol will be delivered via the Posit Science Platform, and includes tasks that emphasize training of sustained attention, salience detection, and dimensions of cognitive control. During the 4 week intervention, participants will have weekly 10-20 minute visits with a Care Manager to provide clinical monitoring of symptoms and structured support to participants.
Intervention Type
Behavioral
Intervention Name(s)
General Cognitive Training Intervention
Intervention Description
In this intervention, participants will complete 25-30 minutes of cognitive activities per day, 5 days/week (but up to 7 days/week) for 4 weeks. The training protocol will be delivered via the Posit Science Platform. The intervention protocol will include computerized cognitive activities designed to provide general cognitive stimulation. During the 4 week intervention, participants will have weekly 10-20 minute visits with a Care Manager to provide clinical monitoring of symptoms and structured support to participants.
Primary Outcome Measure Information:
Title
Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks
Description
Calculated from resting state fMRI scan. Validation of target engagement.
Time Frame
Baseline and Post-treatment (Week 4)
Secondary Outcome Measure Information:
Title
Change in Apathy Evaluation Scale (AES) score
Description
The 18-item clinician-rated version of the Apathy Evaluation Scale (AES) will be used to measure apathy severity. Scores range from 18 (no apathy) to 72 (severe apathy).
Time Frame
Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)
Title
Change in Stroop Interference score
Description
Stroop interference will be calculated from the computerized Stroop Task to measure cognitive control.
Time Frame
Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 60+ years Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Structured Clinical Interview for DSM-5 (SCID) Montgomery-Åsberg Depression Rating Scale (MADRS) score > or = 16. Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES > or = to 37) Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 5 weeks. On a stable dose of other psychotropic medications, deemed by the investigator to be associated with brain networks of interest, for at least 8 weeks. Capacity to provide written consent for research assessment and treatment Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff. DRS total score > 129 or DRS scaled score of 5 based on age and education-adjusted normative data49 Eligible to undergo MRI Access to a computer or tablet with Wifi capabilities Able to comply with all testing and study requirements and willingness to participate in the full study duration. Exclusion Criteria: History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, persistent depressive disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia Use of cholinesterase inhibitors or psychoactive drugs other than antidepressants or benzodiazepines, including antipsychotics, that in the opinion of the Investigator may confound study data/assessments. Presence or history of significant neurologic or neurodegenerative disorder (e.g., Alzheimer's disease and other dementias, amnestic Mild Cognitive Impairment, history of stroke, Multiple Sclerosis, Parkinson's disease, epilepsy). Any other acute medical condition (e.g., cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses) that may influence brain systems of interest or interfere with participation or interpretation of the study results. Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior. Electroconvulsive therapy within the past 12 months Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder. Participant is currently enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is enrolled in psychotherapy, this will not be grounds for exclusion) Claustrophobia Color Blindness Sensory or physical impairment that would preclude cognitive testing or participation in the intervention (e.g., upper limb paralysis) as reported by the participant or observed by the Investigator. Travelling consecutively for 2+ weeks during the study period to a location that will preclude timely collection of post-treatment MRI data. Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, cochlear implant, any other metallic biomedical implant contraindicating to MRI.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Oberlin, PhD
Phone
(646) 289-5204
Ext
707
Email
leo4001@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Oberlin, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lauren Elizabeth Oberlin
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren E Oberlin, PhD
Phone
646-289-5204
Ext
707
Email
leo4001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Lauren Oberlin, PhD
Facility Name
Weill Cornell Medicine Institute of Geriatric Psychiatry
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren E Oberlin, PhD
Phone
646-289-5204
Ext
707
Email
leo4001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Lauren Oberlin, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data that will be shared includes all of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Beginning 3 months following publication of primary outcomes, ending 5 years following publication of primary outcomes.
IPD Sharing Access Criteria
Data will be made available to researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal. Proposals should be directed to the study PI, Lauren Oberlin, at leo4001@med.cornell.edu.

Learn more about this trial

Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics

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