Interventional, Randomised, Double-blind, Placebo-controlled, Fixed-dose Study of Vortioxetine in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 15
- 主要终点
- Change in ADHD Investigator Symptom Rating Scale (AISRS) Total Score
研究概览
简要总结
The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult patients with ADHD in a 12 weeks study.
详细描述
The study employed the Sequential Parallel Comparison Design (SPCD), a clinical study design which intend to increase signal detection by using two stages of treatment:
- Stage 1 - first 6 weeks of the 12-weeks treatment period (Visit 2/Baseline 1 to Visit 5/Week 6)
- Stage 2 - last 6 weeks of the 12-weeks treatment period (Visit 5/Baseline 2 to Visit 8/Week 12)
In Stage 1, patients were randomized to placebo or vortioxetine 10 or 20mg. Patients on vortioxetine 10 or 20mg/day during Stage 1 remained on the same treatment in Stage 2. Responders to placebo in Stage 1 remained on Placebo in Stage 2. Patients who were placebo non-responders during Stage 1, defined as patients with a <30% reduction in AISRS total score from Baseline 1, were re-randomized to placebo or vortioxetine 10 or 20mg/day in Stage 2.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is willing and able to attend study appointments within the specified time windows.
- •The patient is an outpatient.
- •The patient is diagnosed with a primary diagnosis of ADHD according to the DSM-5™ classification.
- •The patient has an AISRS total score ≥
- •The patient has a CGI-S rating ≥4 (moderately ill or worse).
排除标准
- •The patient has previously been treated with vortioxetine.
- •The patient has any current psychiatric disorder (DSM-IV-TR™ criteria), other than ADHD, as assessed using the Mini International Neuropsychiatric Interview (MINI).
- •The patient has a known first-degree relative with bipolar disorder.
- •The patient suffers from intellectual disability as evaluated by the Wechsler Abbreviated Scale of Intelligence (WASI) II vocabulary and matrix.
- •The patient suffers from organic mental disorders, or mental disorders due to a general medical condition (DSM-5™ criteria).
- •The patient has reported current use of, or has tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, benzodiazepines, and cannabinoids). If a patient tests positive for opiates due to incidental use of codeine containing medication, as assessed in a clinical interview, the drug screen may be repeated up to three weeks later but the retest result must be available from the central laboratory latest at Visit 2 and has to be negative for this patient to be eligible for enrolment. If a patient tests positive for amphetamines due to his/her ADHD current treatment, as confirmed by a clinical interview, the patient is eligible for enrolment provided this treatment is discontinued two weeks prior to the Baseline Visit.
- •The patient has a history of two prior failed (<50% improvement in symptoms) adequate trials of ADHD treatment.
- •The patient has any other disorder for which the treatment takes priority over treatment of ADHD or is likely to interfere with study treatment or impair treatment compliance.
- •The patient has a history of moderate or severe head trauma or other neurological disorders or systemic medical diseases that are, in the investigator's opinion, likely to affect central nervous system functioning.
- •The patient has attempted suicide within the last 6 months or is at significant risk of suicide (either in the opinion of the Investigator or defined as a "yes" to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behaviour on the Columbia-Suicide Rating Scale (C-SSRS) within the last 12 months).
- •Other protocol defined inclusion and exclusion criteria do apply
研究组 & 干预措施
vortioxetine 10 mg tablet
In Stage 1, patients will receive vortioxetine 10mg/day for 6 weeks.
In Stage 2, patients who received vortioxetine 10mg/day in Stage 1 will continue on the same treatment for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks.
干预措施: vortioxetine 10 mg tablet (Drug)
Placebo tablet
In Stage 1, the patients will receive placebo for 6 weeks.
In Stage 2, placebo responders will continue on placebo for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks.
干预措施: Placebo tablet (Other)
vortioxetine 20 mg tablet
In Stage 1, patients will receive vortioxetine 20mg/day for 6 weeks.
In Stage 2, patients who received vortioxetine 20mg/day in Stage 1 will continue on the same treatment for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks.
干预措施: vortioxetine 20 mg tablet (Drug)
结局指标
主要结局
Change in ADHD Investigator Symptom Rating Scale (AISRS) Total Score
时间窗: Baseline to Week 6
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
次要结局
- Change AISRS Hyperactivity/Impulsivity Sub-score(Baseline to Week 6)
- Change in AISRS Inattention Sub-score(Baseline to Week 6)
- Change in Perceived Deficits Questionnaire - Depression (PDQ-D) Total Score(Baseline to Week 6)
- Change in PDQ-D Subscales - Attention and Concentration Sub-score(Baseline to Week 6)
- Change in BRIEF-A Using the Behavioural Regulation Index(Baseline to Week 6)
- Change in BRIEF-A Subscales - Inhibit(Baseline to Week 6)
- Change BRIEF-A Subscales - Initiate(Baseline to Week 6)
- Change in BRIEF-A Subscales - Organization of Materials(Baseline to Week 6)
- Change in BRIEF-A Subscales - Planning/Organize(Baseline to Week 6)
- Change in BRIEF-A Subscales - Shift(Baseline to Week 6)
- Change in BRIEF-A Subscales - Self Monitor(Baseline to Week 6)
- Change in BRIEF-A Subscales - Task Monitor(Baseline to Week 6)
- Change in BRIEF-A Subscales - Working Memory(Baseline to Week 6)
- Change in BRIEF-A Subscales - Emotional Control(Baseline to Week 6)
- Change in SDS Item Scores - Family(Baseline to Week 6)
- Change in SDS Item Scores - Work(Baseline to Week 6)
- Change in SDS Item Scores - Social Life(Baseline to Week 6)
- Change in SDS Item Scores - Number of Days Lost(Baseline to Week 6)
- Change in SDS Item Scores - Number of Underproductive Days(Baseline to Week 6)
- Inattention/Meta-cognition: Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Using Metacognition Index(Baseline to Week 6)
- Cognitive Function/Global Executive Function: Change in BRIEF-A Using the Global Executive Composite Score(Baseline to Week 6)
- Overall Functioning: Change in Sheehan Disability Scale (SDS) Total Score(Baseline to Week 6)
- Productivity: Change in Work Limitations Questionnaire (WLQ) Productivity Loss Score(Baseline to Week 6)
- Percentage of Patients Responding (Response Defined as 30% or Greater Reduction From Baseline in AISRS Total Score)(Baseline to Week 6)
- Change in Adult ADHD Self-Report Scale (ASRS) Total Score(Baseline to Week 6)
- Change in Clinical Global Impression - Severity of Illness (CGI-S) Score(Baseline to Week 6)
- Clinical Global Impression - Global Improvement (CGI-I) Score(Week 6)
- Response (Defined as a CGI-I Score of 1 or 2), Stage 1(Week 6)
- Change in PDQ-D Sub-scales - Retrospective Memory Sub-score(Baseline to Week 6)
- Change in PDQ-D Sub-scales - Prospective Memory Sub-score(Baseline to Week 6)
- Change in PDQ-D Sub-scales - Planning and Organisation Sub-score(Baseline to Week 6)
- Change in WLQ Using the Global Productivity Index(Baseline to Week 6)
- Change in WLQ Domain Scores - Limitations Handling Time(Baseline to Week 6)
- Change in WLQ Domain Scores - Mental-Interpersonal Work Demands(Baseline to Week 6)
- Change in WLQ Domain Scores - Physical Demands(Baseline to Week 6)
- Change in WLQ Domain Scores - Output Demands(Baseline to Week 6)
- Change in Adult ADHD Quality of Life Measure (AAQoL) Total Score(Baseline to Week 6)
- Change in AAQoL Subscales - Life Productivity Sub-score(Baseline to Week 6)
- Change in AAQoL Subscales - Psychological Health Sub-score(Baseline to Week 6)
- Change in AAQoL Subscales - Life Outlook Sub-score(Baseline to Week 6)
- Change in AAQoL Subscales - Relationships Sub-score(Baseline to Week 6)