Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836533
Status:
WITHDRAWN
Last Update Posted:
2023-03-28
First Post:
2021-03-29
Brief Title:
Enhancing Processing Speed and Executive Functioning in Depressed Older Adults With Computerized Cognitive Training
Sponsor:
Queens College The City University of New York
Organization:
Queens College The City University of New York
Study Overview
Official Title:
Optimizing Placebo Effects in Depressed Older Adults Enhancing Processing Speed and Executive Functioning With Computerized Cognitive Training
Status:
WITHDRAWN
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Conflicts at the study site prevented the study from being carried out
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to determine how treatment response may change depending on how studies are designed and if mobile cognitive training can be used to improve treatment response in depressed older adults
Detailed Description:
Major Depressive Disorder MDD is a leading cause of disability morbidity and mortality across the lifespan and poses a particularly severe public health problem in late life Late-life depression LLD is highly recurrent can become chronic and is often difficult to treat Antidepressant treatment is often ineffective in this population because of the presence of neurocognitive factors including slow processing speed PS executive dysfunction ED and cerebrovascular disease CVD that interfere with treatment It is crucial therefore that we develop interventions that address antidepressant non-response and dramatically improve the quality of life of millions of vulnerable older adults We recently determined that an important cause of non-response in this population is impaired expectancy effects which in turn are compromised by slow speed of processing We propose therefore that antidepressant non-response in older adults with PS deficits is caused by expectancy failure and that targeting PS deficits prior to antidepressant treatment will restore the capacity to form expectations thereby improving antidepressant treatment response An excellent candidate for improving PS is computerized cognitive training CCT ie exercises that target train and strengthen specific cognitive processes with the use of structured drills and repeated practice
To test our expectancy-processing speed model 100 depressed adults age 60 and over with PS deficits will be recruited Participants will be randomized to either CCT or control Solitaire for 4 weeks Both conditions will train 25 minutes per day 7 days per week At the conclusion of this four-week period patients will be randomly assigned to high versus low expectancy treatment conditions Patients assigned to the low expectancy condition will be told they will receive either placebo or escitalopram when in fact they will receive escitalopram for eight weeks Patients assigned to the high expectancy condition will be told they will receive escitalopram for eight weeks Neuropsychological assessment will occur at baseline and weeks 4 and 12 whereas MRI scans will be conducted at baseline and week 4
Clinical assessments will be conducted biweekly throughout the study The goals of this study are to 1 To determine whether PS mediates the relationship between CCT and expectancy and 2 To compare endpoint depression scores as a function of CCT and expectancy conditions
At the screening evaluation informed consent for the screening evaluation is obtained Participants subsequently undergo a psychiatric clinical interview using the Structured Clinical Interview Diagnostic for DSM-V SCID-V 24- item Hamilton Rating Scale for Depression HRSD Clinical Global Impressions Scale - Severity CGI-Severity Cumulative Illness Rating Scale for Geriatrics CIRS-G and Antidepressant Treatment History Form ATHF to document depression diagnosis severity and medical comorbidity WAIS-IV Digit Symbol Coding will be completed to determine whether the patient meets inclusion criteria for PS 1 SD on age adjusted norms If the patient is eligible for study entry participation in the research protocol will be discussed and informed consent will be obtained After consent is obtained patients will receive a comprehensive baseline neuropsychological assessment and MRI structural resting state and DTI Neuropsychological assessments include MMSE WAIS-IV Coding NIH Toolbox Cognition Battery NIH Supplement Auditory Verbal Learning Test Rey Trail Making Test Part A and B Stroop Color-Word Test and The Letter and Animal Naming Test These measures will capture global cognitive functioning processing speed attention and response inhibition and verbal fluency After testing patients will be randomized to either CCT or active control for 4 weeks 25day 7 daysweek Patients randomized to CCT will complete seven 25-minute sessions per week for 4 weeks using BrainHQs Double Decision in the experimental condition a processing speed exercise and BrainHQ solitaire in the control condition At the conclusion of this four-week period patients will complete a second neuropsychological assessment and a second fMRI to determine change in resting-state BOLD signal in the CCN Patients will then be randomly assigned to high versus low expectancy treatment conditions Patients assigned to the low expectancy condition will be told they will receive either placebo escitalopram when in fact they will receive escitalopram for eight weeks Patient assigned to the high expectancy condition will be told and they will receive escitalopram for eight weeks Expectancy is measured at baseline and after informing patients of their randomization status The difference between their pre and post randomization expectancy regarding treatment improvement is the expectancy effect At the conclusion of the eight-week clinical trial the difference in antidepressant response observed between the open and placebo-controlled medication treatments is a measure of the expectancy contribution to outcome Neuropsychological assessment will occur again at the conclusion of the escitalopram trial week 12 Clinical assessments will be conducted biweekly throughout the study
The novel experimental therapeutics approach taken in this proposal cuts across several research themes prevention and translation and addresses many of the challenges digital technology and neural circuits elaborated in NIMHs Strategic Plan for mental health research in the 21st century Consistent with NIMH goals it also develops strategies for tailoring existing interventions to optimize outcomes and elucidates the mechanism by which antidepressant treatment in LLD can be restored
To test our expectancy-processing speed model 100 depressed adults age 60 and over with PS deficits will be recruited Participants will be randomized to either CCT or control Solitaire for 4 weeks Both conditions will train 25 minutes per day 7 days per week At the conclusion of this four-week period patients will be randomly assigned to high versus low expectancy treatment conditions Patients assigned to the low expectancy condition will be told they will receive either placebo or escitalopram when in fact they will receive escitalopram for eight weeks Patients assigned to the high expectancy condition will be told they will receive escitalopram for eight weeks Neuropsychological assessment will occur at baseline and weeks 4 and 12 whereas MRI scans will be conducted at baseline and week 4
Clinical assessments will be conducted biweekly throughout the study The goals of this study are to 1 To determine whether PS mediates the relationship between CCT and expectancy and 2 To compare endpoint depression scores as a function of CCT and expectancy conditions
At the screening evaluation informed consent for the screening evaluation is obtained Participants subsequently undergo a psychiatric clinical interview using the Structured Clinical Interview Diagnostic for DSM-V SCID-V 24- item Hamilton Rating Scale for Depression HRSD Clinical Global Impressions Scale - Severity CGI-Severity Cumulative Illness Rating Scale for Geriatrics CIRS-G and Antidepressant Treatment History Form ATHF to document depression diagnosis severity and medical comorbidity WAIS-IV Digit Symbol Coding will be completed to determine whether the patient meets inclusion criteria for PS 1 SD on age adjusted norms If the patient is eligible for study entry participation in the research protocol will be discussed and informed consent will be obtained After consent is obtained patients will receive a comprehensive baseline neuropsychological assessment and MRI structural resting state and DTI Neuropsychological assessments include MMSE WAIS-IV Coding NIH Toolbox Cognition Battery NIH Supplement Auditory Verbal Learning Test Rey Trail Making Test Part A and B Stroop Color-Word Test and The Letter and Animal Naming Test These measures will capture global cognitive functioning processing speed attention and response inhibition and verbal fluency After testing patients will be randomized to either CCT or active control for 4 weeks 25day 7 daysweek Patients randomized to CCT will complete seven 25-minute sessions per week for 4 weeks using BrainHQs Double Decision in the experimental condition a processing speed exercise and BrainHQ solitaire in the control condition At the conclusion of this four-week period patients will complete a second neuropsychological assessment and a second fMRI to determine change in resting-state BOLD signal in the CCN Patients will then be randomly assigned to high versus low expectancy treatment conditions Patients assigned to the low expectancy condition will be told they will receive either placebo escitalopram when in fact they will receive escitalopram for eight weeks Patient assigned to the high expectancy condition will be told and they will receive escitalopram for eight weeks Expectancy is measured at baseline and after informing patients of their randomization status The difference between their pre and post randomization expectancy regarding treatment improvement is the expectancy effect At the conclusion of the eight-week clinical trial the difference in antidepressant response observed between the open and placebo-controlled medication treatments is a measure of the expectancy contribution to outcome Neuropsychological assessment will occur again at the conclusion of the escitalopram trial week 12 Clinical assessments will be conducted biweekly throughout the study
The novel experimental therapeutics approach taken in this proposal cuts across several research themes prevention and translation and addresses many of the challenges digital technology and neural circuits elaborated in NIMHs Strategic Plan for mental health research in the 21st century Consistent with NIMH goals it also develops strategies for tailoring existing interventions to optimize outcomes and elucidates the mechanism by which antidepressant treatment in LLD can be restored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R33MH126187 | NIH | None | httpsreporternihgovquickSearchR33MH126187 |