Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- NIH Examiner
研究概览
简要总结
The goal of this clinical trial is to learn if a combination of non-drug treatments works to benefit memory, thinking, and brain functioning in older individuals with recurrent depression. The non-drug approaches the investigators are studying include transcranial direct current stimulation (tDCS) and computerized cognitive training. tDCS uses small currents of electricity on the forehead to potentially stimulate your brain's ability to process and learn. Computerized cognitive training uses tablet games to improve memory and thinking.
In this study, two different cognitive training programs are being investigated, both of which are stimulating and designed to engage brain activity. One that is believed to be a specific treatment for depression, while the other provides extra stimulation for the brain that is non-specific. Two different tDCS parameters - active stimulation and sham (or placebo) stimulation - are also being investigated.
Participants will be randomized to one of three study groups:
- Depression cognitive training treatment with active brain stimulation
- Depression cognitive training treatment with sham brain stimulation
- Non-specific cognitive training treatment with sham brain stimulation
The main questions this clinical trial aims to answer are:
- Does "depression cognitive training treatment with active brain stimulation" benefit thinking and memory more so than the other treatments?
- Does "depression cognitive training treatment with active brain stimulation" benefit brain functioning more so than the other treatments?
Participants will:
- Complete several baseline and post-intervention visits at the research center for checkups and tests over the course of 3-4 months.
- Visit the research center daily for 4 weeks to complete their assigned treatment.
详细描述
The purpose of this study is to determine whether stepwise engagement of the frontal lobe across randomized groups (active tDCS+depression cognitive training > sham tDCS+depression cognitive training > sham tDCS+non-specific cognitive training) will result in progressively greater improvements in executive functions and memory, as well as intrinsic functional connectivity of the Executive Control Network (ECN), in older adults with recurrent depression. The investigators will randomize 69 elderly depressed outpatients into one of three conditions daily over 4-weeks. Psychiatric and neuropsychological evaluations, as well as multimodal neuroimaging (focused on the ECN) will be obtained at baseline and following intervention completion to look at acute and long-term effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple-blinded
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 60 years
- •Evidence of executive dysfunction via SUBJECTIVE COMPLAINTS (At least one subdomain of the Behavior Rating Inventory of Executive Function in Adults (BRIEF-A) at T > 65, or At least one average score of > 1.5 on Planning, Organization, or Attention subdomains of the Everyday Cognition Scale (ECog)) or OBJECTIVE PERFORMANCE (At least one demographically adjusted z-score > -1.0 SD below the mean on a measure of executive functioning (Digits backward, Trails B, or total Verbal Fluency) on the National Alzheimer's Coordinating Center (NACC) Uniform Data Set 3.0).
- •DSM-5 diagnosis of a current or past (within last 3 years) depressive episode (e.g., Major Depressive Disorder (MDD), Persistent Depressive Disorder (PDD)) via the using the Structured Clinical Interview for DSM-5 Disorders (SCID-5).
- •Presence of 2 or more lifetime depressive episodes to be considered "recurrent."
- •Either stable antidepressant regimen for at least 6 weeks or no current antidepressant treatment (no plans to change treatment over course of study).
- •Fluent in English
排除标准
- •Other psychiatric conditions via the SCID-5 (including history of bipolar disorder and psychosis, excluding comorbid anxiety disorders)
- •Severe depression (MADRS score > 29)
- •Acute suicidality on clinical evaluation by study clinician and via response on MADRS item 10 (score of 4 or more would require further assessment)
- •Acute grief (occurring within past month)
- •History of alcohol use disorder or substance use disorder of moderate or greater severity in the last 12 months
- •Medications that would significantly interfere with tDCS effects (i.e., sodium channel blockers, GABA-ergic or glutamatergic drugs; see Appendix B for exclusionary list)40
- •Primary neurological disorder (e.g., epilepsy, brain tumor, Parkinson's disease, Alzheimer's disease, dementia diagnosis)
- •Montreal Cognitive Assessment (MoCA) < 23
- •Primary amnestic cognitive profile (>1.5 SD below demographically-adjusted mean on NACC memory measures in context otherwise normal cognitive profile, or per clinician judgement)
- •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). Observational studies [without intervention] are acceptable.
研究组 & 干预措施
Depression Cognitive Training + Active Stimulation
This arm receives the depression cognitive training combined with active tDCS.
干预措施: Depression Cognitive Training (Behavioral)
Depression Cognitive Training + Active Stimulation
This arm receives the depression cognitive training combined with active tDCS.
干预措施: tDCS (active stimulation) (Device)
Depression Cognitive Training + Sham Stimulation
This arm receives the depression cognitive training combined with sham tDCS.
干预措施: tDCS (sham stimulation) (Device)
Depression Cognitive Training + Sham Stimulation
This arm receives the depression cognitive training combined with sham tDCS.
干预措施: Depression Cognitive Training (Behavioral)
Non-Specific Cognitive Training + Sham Stimulation
This arm receives the non-specific cognitive training combined with sham tDCS.
干预措施: tDCS (sham stimulation) (Device)
Non-Specific Cognitive Training + Sham Stimulation
This arm receives the non-specific cognitive training combined with sham tDCS.
干预措施: Non-Specific Cognitive Training (Behavioral)
结局指标
主要结局
NIH Examiner
时间窗: Baseline, Following completion of the 4-week intervention, 3-month Post-Intervention
This objective cognitive test battery assesses a range of executive functions (working memory, inhibition, set shifting, fluency, and planning). The investigators will examine intervention-related change its Executive Composite Score (primary outcome), and subcomposite (Cognitive Control, Working Memory, and Fluency; secondary outcomes) scores, where higher scores indicate better performance.
Resting state fMRI functional connectivity
时间窗: Baseline, Following completion of the 4-week intervention
Functional connectivity from resting state fMRI will be processed using the CONN toolbox for connectivity, incorporating the Shaeffer network atlases to improve peer-research supported network usage in addition to the standard CONN atlases. A priori ROI-to-ROI analyses will be used to determine whether average connectivity changes in the Executive Control Network differs by treatment group. Analyses will control for multiple comparisons at false discovery rate (FDR) \< 0.05.
次要结局
- Montgomery Asberg Depression Rating Scale(Baseline and weekly thereafter, Following completion of the 4-week intervention, 3-Month Post-Intervention)
研究者
Sarah Szymkowicz
Assistant Professor
Vanderbilt University Medical Center