Enhancing Processing Speed and Executive Functioning in Depressed Older Adults With Computerized Cognitive Training

NCT04836533 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: MH126187R33MH126187
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression in Old Age; Depression

Outcome Measures

Primary Outcomes (6)

• Hamilton Rating Scale for Depression (HRSD) Change

  Clinician-rated measure of depressive severity composed of 24 questions used to measure changes in depressive symptoms and monitor safety during the study.

  Screen, Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12

• Treatment Credibility Expectancy Scale (CES) - item 4 Change

  Self-report scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. Item 4 measures how much improvement in depression symptoms is expected.

  Baseline, Week 0

• Processing Speed Change - WAIS-IV Coding

  Processing speed will be assessed using Coding from the Wechsler Adult Intelligence Scale-IV (WAIS-IV), the NIH Toolbox Pattern Comparison Processing Speed Test, and Trail Making Test A. From these 3 tests, a composite score (primary outcome) is derived by extracting a latent factor and factor loadings, creating a purer measure of processing speed than raw scores from an individual test or a sum total score.

  Baseline, Weeks 4, 12

• Processing Speed Change - NIHH Toolbox Pattern Comparison Processing Speed Test

  Processing speed will be assessed using Coding from the Wechsler Adult Intelligence Scale-IV (WAIS-IV), the NIH Toolbox Pattern Comparison Processing Speed Test, and Trail Making Test A. From these 3 tests, a composite score (primary outcome) is derived by extracting a latent factor and factor loadings, creating a purer measure of processing speed than raw scores from an individual test or a sum total score.

  Baseline, Weeks 4, 12

• Processing Speed Change - Trail Making Test A

  Processing speed will be assessed using Coding from the Wechsler Adult Intelligence Scale-IV (WAIS-IV), the NIH Toolbox Pattern Comparison Processing Speed Test, and Trail Making Test A. From these 3 tests, a composite score (primary outcome) is derived by extracting a latent factor and factor loadings, creating a purer measure of processing speed than raw scores from an individual test or a sum total score.

  Baseline, Weeks 4, 12

• Resting State Functional Connectivity Index Change

  Measure of resting state fMRI.

  Baseline, Week 4

Secondary Outcomes (16)

• Secondary Clinical Global Impressions (CGI) Severity and Improvement

  Screen, Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12

• Inventory for Depressive Symptomatology Self-Report (IDS-SR)

  Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12

• Cumulative Illness Rating Scale for Geriatrics (CIRS-G)

  Screen

• NIH Toolbox Auditory Verbal Learning Test - Rey (RAVLT)

  Baseline, Weeks 4, 12

• Stroop Color-Word Test (Stroop)

  Measure of response inhibition sensitive to frontal lobe dysfunction. This test is divided into three conditions: color naming, word reading, and colorword inhibition.

Other Outcomes (3)

• Structured Clinical Interview Diagnostic for DSM-V (SCIDV)

  Screen

• Mini-Mental Status Exam (MMSE)

  Screen

• Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Symbol Coding

  Screen, Weeks 4, 12

Study Arms (4)

Computerized Cognitive Training

EXPERIMENTAL

Those assigned to the computerized cognitive training arm prior to antidepressant trial enrollment will receive computerized cognitive training that includes games that scale in difficulty.

Other: Experimental: Computerized Cognitive Training

Solitaire Training

ACTIVE COMPARATOR

Those assigned to the solitaire training arm prior to antidepressant trial enrollment will receive computerized solitaire games.

Other: Active Comparator: Solitaire Training

Open-label antidepressant treatment

EXPERIMENTAL

Those assigned to receive open-label antidepressant treatment will begin with 10 mg of escitalopram. If the participant cannot tolerate or has an adverse reaction to escitalopram, duloxetine will be offered instead.

Drug: Experimental: Open-label antidepressant treatment

Placebo-controlled antidepressant treatment

PLACEBO COMPARATOR

Those assigned to the placebo-controlled group will be told that they have a 50/50 chance of receiving either escitalopram or placebo.

Other: Placebo Comparator: Placebo-controlled antidepressant treatment

Interventions

Experimental: Computerized Cognitive Training OTHER

Participants will complete 4 weeks of executive functioning / processing speed training through the BrainHQ platform on their personal computers.

Computerized Cognitive Training

Experimental: Open-label antidepressant treatment DRUG

Participants will be assigned to open-label or placebo-controlled antidepressant treatment for 8 weeks.

Open-label antidepressant treatment

Active Comparator: Solitaire Training OTHER

Participants will complete 4 weeks of Solitaire training through the BrainHQ platform on their personal computers.

Solitaire Training

Placebo Comparator: Placebo-controlled antidepressant treatment OTHER

Participants will be told they have a 50/50 chance of receiving a placebo or antidepressant.

Placebo-controlled antidepressant treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 60 years
• DSM5 Diagnosis of Major Depressive Disorder (MDD), Persistent Depressive Disorder, or Depression Not Otherwise Specified (NOS)
• Hamilton Rating Scale for Depression (HRSD) score ≥ 20
• Decreased processing speed (1 SD below age-adjusted norms on the WAIS-IV Digit Symbol Coding Test)
• Access to a computer with daily internet access
• Willing to and capable of providing informed consent and complying with all study procedures. At the end of the CCT phase (week 4), depression severity will be reassessed. To be eligible for Phase 2 (SSRI trial), participants will be required to have an HRSD score ≥ 14.

You may not qualify if:

• Diagnosis of substance abuse or dependence (excluding Tobacco Use Disorder) within the past 12 months
• History of psychosis, psychotic disorder, mania, or bipolar disorder
• Primary neurological disorder, including dementia, stroke, Parkinson's disease, epilepsy, etc.
• Mini Mental Status Examination (MMSE) score less than 24
• HRSD suicide item greater than 2 or Clinical Global Impressions (CGI)-Severity score of 7 at baseline
• History of allergic or adverse reaction to escitalopram, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20 mg) during the current episode
• Current or recent (within the past 2 weeks) treatment with psychotherapy, antidepressants, antipsychotics, mood stabilizers
• Contraindication to MRI scanning (such as metal in body) or inability to tolerate the scanning procedures
• History of significant radioactivity exposure (nuclear medicine studies or occupational exposure).

Sponsors & Collaborators

• Queens College, The City University of New York: lead
• National Institute of Mental Health (NIMH): collaborator
• New York State Psychiatric Institute: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Joel R Sneed, PhD

  Queens College and NYSPI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 8, 2021
• Study Start: January 31, 2023
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: March 28, 2023

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)