NCT05296473已完成不适用
Guided ADHD Therapy for Managing the Extent and Severity of Symptoms - A Randomized, Controlled, Parallel-group, Intervention Study to Assess an At-home, Game-based Digital Therapy for Treating Adult Patients With Attention-Deficit/Hyperactivity Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 560
- 试验地点
- 26
- 主要终点
- Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS)
研究概览
简要总结
The objective of this study is to assess the safety and effectiveness of an at-home, game-based digital therapy for treating adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).
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)
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 22-55 years of age
- •Male or female
- •Confirmed ADHD diagnosis, combined or inattentive type, at Screening based on DSM-5 criteria and established via the MINI-Adult, administered by a trained clinician
- •Baseline score on the clinician-rated ADHD-RS total score ≥28
- •Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products at time of Screening; or, if undergoing pharmacological treatment, must be willing and appropriate (i.e., not optimally treated in the Investigator's judgement or having issues with tolerability) to wash out of current regimen
- •Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
- •Ability to understand and speak English, follow written and verbal instructions (English), as assessed by the PI and/or Study Coordinator, and give informed consent (English)
- •Have ability to connect wireless devices to a functional wireless network on a daily basis
- •Ability to comply with all the testing and study requirements
排除标准
- •Current, controlled (requiring restricted medication) or uncontrolled, comorbid psychiatric diagnosis, based on MINI-Adult and subsequent clinical interviewing, with significant symptoms including but not limited to posttraumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments.
- •Patients who are currently treated with a non-stimulant medication for ADHD (i.e., atomoxetine, clonidine, guanfacine, viloxazine)
- •Have previously been assessed by TOVA for potential enrollment in a clinical trial.
- •Have previously used a videogame-like digital therapy (e.g., Akili EndeavorRxTM) OR Within the last three years, have used a cognitive or brain training platform (e.g., Peak, Brain HQ, Lumosity, Atentiv) for more than two weeks duration
- •Known sensitivity to playing video games, such as headaches, dizziness, nausea.
- •Initiation within the last 4 weeks of behavioral therapy or neurofeedback, or planned initiation during the study. Patients who have been in behavior therapy or neurofeedback consistently for more than 4 weeks may participate provided their routine is unchanged during the course of the study. Patients planning on changing or initiating behavior therapy or neurofeedback during the course of the study will be excluded.
- •Patient is currently considered a suicide risk in the opinion of the Investigator, as measured by C-SSRS at screening (i.e., score of 4 or 5 on C-SSRS)
- •Motor condition (e.g., physical deformity of the hands/arms; protheses) that prevents game playing as observed by the Investigator
- •Recent history (within the past 12 months) of suspected alcohol or substance abuse or dependence
- •Positive urine drug screen
- •History of seizures (excluding febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder and photo-sensitive epilepsy
- •Visual acuity that cannot be corrected that prevents or negatively impacts game playing as observed by the Investigator
- •Any use of psychoactive drugs (other than stimulant) that in the opinion of the Investigator may confound study data/assessments
- •Has participated in a clinical trial within 90 days prior to screening
- •Has a family member or close friend/associate also enrolled/currently participating in the same study
- •Any other condition that in the opinion of the Investigator may confound study data/assessments
结局指标
主要结局
Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS)
时间窗: Study Day 0 to Study Day 63
The TOVA is a standardized, computerized, continuous performance test (CPT). The TOVA Attention Comparison Score (ACS) is a comparison of a subject's scores to scores from a normative ADHD population. A score of \< 0 indicates a subject's performance is similar to that of the normative ADHD population, with a lower score indicating a more severe ADHD profile. A positive change on the TOVA ACS from Day 0 to Day 63 indicates improvement.
次要结局
- Clinical Global Impression Scale - Improvement (CGI-I)(at Study Day 63)
- Cambridge Brain Sciences Spatial Span(Study Day 0 to Study Day 63)
- ADHD-RS-5 Inattention Subscale with Adult Prompts(Study Day 0 to Study Day 63)
- Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Working Memory and Inhibit Percentiles(Study Day 0 to Study Day 63)
- Weiss Functional Impairment Rating Scale - Self-Report (WFIRS-S)(Study Day 0 to Study Day 63)
- Cambridge Brain Sciences Token Search(Study Day 0 to Study Day 63)
研究者
研究点 (26)
Loading locations...
相似试验
进行中（未招募）
不适用
An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of SymptomsADHDNCT05805176Lumos Labs, Inc.194
已完成
不适用
An Internet-delivered Intervention for Parents of Children With ADHDADHDNCT05341310Babes-Bolyai University86
终止
不适用
Therapeutic Gaming for the Treatment of Attention Deficit Hyperactivity DisorderAttention Deficit Hyperactivity DisorderNCT05067322Spherix Incorporated2
已完成
不适用
A Novel Device for the Management of ADHDADHDNCT05777785VIZO Specs Ltd108
已完成
不适用
A Novel, Non-pharmacological, Intervention for the Management of ADHD in AdolescentsADHDNCT05835336VIZO Specs Ltd32