Cognitive Enhancement in Depression (The COG-D Study)

Depression Clinical Trial

Official title:

Non-invasive Neuromodulation to Enhance Targeted Cognitive Remediation in Older Adults With Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400512
• Other study ID #: 220283
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Sarah M. Szymkowicz, PhD
• Phone: 615-875-0032
• Email: sarah.szymkowicz[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate whether transcranial direct current stimulation (tDCS) enhances the effects of cognitive training in older adults with depression.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Cognitive Symptom
• Depression
• Depressive Disorder
• Neurobehavioral Manifestations

Intervention

Behavioral:
• Cognitive Training
Computerized cognitive training targeting the underlying cerebral networks associated with depression.

Device:
• tDCS (active stimulation)
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).
• tDCS (sham stimulation)
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	American Academy of Neurology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to post-intervention (4-6 weeks)
Secondary	Change in Montgomery Asberg Depression Rating Scale (MADRS) scores)	Clinician-rated measure of depression severity, with higher scores indicative of greater depression severity.	Baseline and weekly thereafter until post-intervention (4-6 weeks)