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Cognitive Enhancement in Depression (The COG-D Study)

Primary Purpose

Aging, Depression, Cognitive Symptom

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
tDCS (active stimulation)
tDCS (sham stimulation)
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring geriatrics, aging, elderly, cognition, memory, depression, tDCS, cognitive training, cognitive remediation

Eligibility Criteria

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

Inclusion Criteria:

  • Age 60+ years
  • Diagnosis of Major Depressive Disorder (MDD; Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria)
  • Either stable antidepressant regimen for at least 6 weeks or no current antidepressant treatment
  • Depression severity of 15+ on the MADRS
  • Evidence of subjective cognitive complaints on the Everyday Cognition Scale (ECog)
  • English fluency

Exclusion criteria:

  • Other Axis I psychiatric disorders, except for generalized anxiety disorder (GAD) symptoms occurring in a depressive episode
  • Acute suicidality on clinical evaluation
  • Currently taking medications that would significantly interact with tDCS effects (such as sodium channel blockers or anticonvulsants)
  • Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury, Parkinson's disease)
  • Montreal Cognitive Assessment (MoCA) score < 23
  • Primary amnestic cognitive profile (>1.5 standard deviations (SDs) below demographically-adjusted mean on National Alzheimer's Coordinating Center (NACC) memory measures in context of otherwise normal cognitive profile)
  • Any physical or intellectual disability affecting ability to complete assessments
  • Unstable medical illness needing urgent treatment
  • MRI contraindications
  • Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in last 2 months
  • Current involvement in psychotherapy
  • Current involvement in other research studies (including but not limited to: neuromodulation [TMS or tDCS] or investigational drug studies)

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cognitive Training + Active Stimulation

Cognitive Training + Sham Stimulation

Arm Description

This arm receives cognitive training combined with active tDCS.

This arm receives cognitive training combined with sham tDCS.

Outcomes

Primary Outcome Measures

Change in NIH Examiner scores
This cognitive test battery assesses a range of executive functions (working memory, inhibition, set shifting, fluency, insight, and planning). The investigators will examine its Executive Composite Score, with higher scores indicate better performance.

Secondary Outcome Measures

Change in Montgomery Asberg Depression Rating Scale (MADRS) scores)
Clinician-rated measure of depression severity, with higher scores indicative of greater depression severity.

Full Information

First Posted
May 27, 2022
Last Updated
March 15, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
American Academy of Neurology
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1. Study Identification

Unique Protocol Identification Number
NCT05400512
Brief Title
Cognitive Enhancement in Depression (The COG-D Study)
Official Title
Non-invasive Neuromodulation to Enhance Targeted Cognitive Remediation in Older Adults With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
American Academy of Neurology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will investigate whether transcranial direct current stimulation (tDCS) enhances the effects of cognitive training in older adults with depression.
Detailed Description
The purpose of this study is to determine whether the addition of active tDCS to computerized cognitive remediation (nCCR) enhances brain activity and cognitive functions in older adults with depression to a greater degree than nCCR with sham stimulation. The investigators will randomize 20 elderly depressed outpatients to either double-blinded active or sham bifrontal tDCS plus daily nCCR over 4-weeks. Multimodal MRI (focused on the cognitive control network; CCN) and psychiatric and neuropsychological evaluations will be obtained at baseline and following intervention completion. Long-term CCN cognitive effects will be explored 3-months post-intervention via cognitive assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Depression, Cognitive Symptom
Keywords
geriatrics, aging, elderly, cognition, memory, depression, tDCS, cognitive training, cognitive remediation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Training + Active Stimulation
Arm Type
Experimental
Arm Description
This arm receives cognitive training combined with active tDCS.
Arm Title
Cognitive Training + Sham Stimulation
Arm Type
Experimental
Arm Description
This arm receives cognitive training combined with sham tDCS.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Computerized cognitive training targeting the underlying cerebral networks associated with depression.
Intervention Type
Device
Intervention Name(s)
tDCS (active stimulation)
Intervention Description
A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0 milliamps (mA) direct current through two bicarbon rubber electrodes encased in saline soaked 5 cm x 7 cm sponges (8 cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (via 10-20 system).
Intervention Type
Device
Intervention Name(s)
tDCS (sham stimulation)
Intervention Description
Sham stimulation will be performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
Primary Outcome Measure Information:
Title
Change in NIH Examiner scores
Description
This cognitive test battery assesses a range of executive functions (working memory, inhibition, set shifting, fluency, insight, and planning). The investigators will examine its Executive Composite Score, with higher scores indicate better performance.
Time Frame
From baseline to post-intervention (4-6 weeks)
Secondary Outcome Measure Information:
Title
Change in Montgomery Asberg Depression Rating Scale (MADRS) scores)
Description
Clinician-rated measure of depression severity, with higher scores indicative of greater depression severity.
Time Frame
Baseline and weekly thereafter until post-intervention (4-6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 60+ years Diagnosis of Major Depressive Disorder (MDD; Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria) Either stable antidepressant regimen for at least 6 weeks or no current antidepressant treatment Depression severity of 15+ on the MADRS Evidence of subjective cognitive complaints on the Everyday Cognition Scale (ECog) English fluency Exclusion criteria: Other Axis I psychiatric disorders, except for generalized anxiety disorder (GAD) symptoms occurring in a depressive episode Acute suicidality on clinical evaluation Currently taking medications that would significantly interact with tDCS effects (such as sodium channel blockers or anticonvulsants) Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury, Parkinson's disease) Montreal Cognitive Assessment (MoCA) score < 23 Primary amnestic cognitive profile (>1.5 standard deviations (SDs) below demographically-adjusted mean on National Alzheimer's Coordinating Center (NACC) memory measures in context of otherwise normal cognitive profile) Any physical or intellectual disability affecting ability to complete assessments Unstable medical illness needing urgent treatment MRI contraindications Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in last 2 months Current involvement in psychotherapy Current involvement in other research studies (including but not limited to: neuromodulation [TMS or tDCS] or investigational drug studies)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah M. Szymkowicz, PhD
Phone
615-875-0032
Email
sarah.szymkowicz@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah M. Szymkowicz, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah M Szymkowicz, PhD
Phone
615-875-0032
Email
sarah.szymkowicz@vumc.org
First Name & Middle Initial & Last Name & Degree
Sarah M Szymkowicz, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Enhancement in Depression (The COG-D Study)

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