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临床试验/NCT02477280
NCT02477280已完成4 期

Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the Quantified Behavior Test in Patients With Untreated ADHD and Substance Use Disorder

Region Västmanland1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
39
试验地点
1
主要终点
Change in Weighted summary parameter QbInattention score on the QbTest.

研究概览

简要总结

Aim: The purpose of the study is to examine the effects of medication, placebo and expectation on objective and self-rated performance of ADHD core signs during the Quantified Behavior Test in patients with untreated ADHD and substance Use Disorders.

Subjects: Participants are 40 consecutive patients remitted to a neuropsychiatric investigation at the Dependence Clinic Västmanland, Västerås, Sweden.

Method: The study is a double-blind, randomized, placebo-controlled, cross-over study. The study is taken place during four hours on two investigating days, separated by a 4 days wash-out period.

All patients participate on two occasions: In one session they receive the Methylphenidate (MPH) condition, and in the other session they receive the placebo condition. MPH and placebo conditions are counterbalanced across subjects such that half of the participants receive MPH first, and half receive placebo first. Neither the patient nor the research assistant is aware when the participant receive the MPH condition or the placebo condition.

On each investigating day the participant accomplish Questionnaires (Visual Analogical Scales) concerning; (a) expectation, (b) self-rated performance, (c) exhausting exercise, (d) perceived help from the pill and (e) self-rated symptoms. In addition the participant completed A Quick Test of Cognitive Speed (AQT) and two separate Quantified Behavior Test Plus (QbTest) without medication vs MPH/Placebo. QbTest aims to provide objective information regarding core-symptoms of ADHD; hyperactivity on the basis of motor-activity measured with the camera, and inattention and impulsivity on basis of the CPT-test.

详细描述

Introduction: During the last decade, neuropsychiatric impairments in adults have more often been observed. Requests for neuropsychiatric investigations, especially concerning Attention Deficit Hyperactivity Disorder (ADHD) has increased. The core ADHD symptoms in adults include a frequent and persistent pattern of inattention/distractibility and/or hyperactivity/impulsivity (Adler 2004; Adler & Chua 2002; McGough & Barkley 2004). In a Swedish study, 22 % of the outpatients in general psychiatric care, were diagnosed with ADHD (Nylander et al 2009).

Individuals with ADHD also have an increased risk for other psychiatric disorders, e.g. major depressive episodes, bipolar disorder, anxiety disorders and antisocial personality disorder (Rasmussen & Levander 2009; Torgersen, Gjervan & Rasmussen 2006). The co-occurrence of ADHD and substance use disorder (SUD) is a prevalent phenomenon that has been demonstrated in numerous studies over the past decade (Arias et al 2008; Bernardi et al 2012; van Emmerik-van Oortmerssen et al 2012).

The prevalence of substance abuse in adults with ADHD has been estimated at 50 % and among addicts seeking treatment, one third of the patients are identified as probable ADHD, when screening instruments have been used (Sullivan & Rodnik-Levin 2001; Ohlmeier et al 2008). The National Board of Health and Welfare in Sweden noted that the presence of people with ADHD and substance abuse varies between 20 % and 35 % depending on what kind of drugs that have been used (Socialstyrelsen 2002).

Pharmacotherapy, mainly with central stimulant medication, is considered to be the treatment of choice for ADHD. In addition, there are patients who request an ADHD diagnosis to obtain drug treatment (Harrison, Edwards & Parker 2007).

Patients' expectation can influence the outcome of a treatment (Bingel et al 2011). Linde et al showed that patients with high expectations before the acupuncture treatment, achieved better treating result than the patients who had lower expectations of treatment (Linde, Fässler & Meissner 2011). A person's expectation is an important part of the so-called placebo effect . The placebo effect is well known and clinically important phenomenon in the patient's treatment. Extensive research has been conducted to elucidate this (Meissner et al 2011; Collocca et al 2013; Enck et al 2013).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years old or older.
  • •ADHD is diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5 criteria).
  • •Substance Use Disorder is diagnosed according to DSM-5 criteria.
  • •Qb-score 1.3 or higher on at least one of the weighted summary parameters QbActivity, QbInattention or QbImpulsivity on the QbTest.
  • •Participants are given their written informed consent to participate in the study.

排除标准

  • •Affected by alcohol or drugs during the last month.
  • •Untreated severe comorbid psychiatric or somatic illness.
  • •Bloodpressure 150/95 or higher.
  • •Irregular pulse, or pulse 100 or higher.
  • •No counter indications according to the Medikinet pill.
  • •Concurrent clinical diagnosis that significantly could affect test performance.
  • •Concurrent prescription of medicines for ADHD or medicines that significantly could affect test performance.

研究组 & 干预措施

Methylphenidate

Experimental

Methylphenidate 20 mg Tablet single-dose per os

干预措施: Methylphenidate (Drug)

Placebo

Placebo Comparator

Placebo 20 mg Tablet single-dose per os

干预措施: Placebo (Drug)

Methylphenidate

Experimental

Methylphenidate 20 mg Tablet single-dose per os

干预措施: Placebo (Drug)

Placebo

Placebo Comparator

Placebo 20 mg Tablet single-dose per os

干预措施: Methylphenidate (Drug)

结局指标

主要结局

Change in Weighted summary parameter QbInattention score on the QbTest.

时间窗: Baseline, 2 hours

Evaluating change in weighted summary parameter QbInattention score on the QbTest.

次要结局

  • Change in Self-rated experienced performance on the QbTest assessed by a Visual Analogue Scale.(Baseline, 2 hours)
  • Change in Weighted summary parameter QbImpulsivity score on the QbTest.(Baseline, 2 hours)
  • Change in Self-rated expected performance on the QbTest assessed by a Visual Analogue Scale.(Baseline, 2 hours)
  • Change in Self-rated mental effort during the QbTest assessed by a Visual Analogue Scale.(Baseline, 2 hours)
  • Change in Weighted summary parameter QbActivity score on the QbTest.(Baseline, 2 hours)
  • Change in Self-rated help from the pill during the QbTest assessed by a Visual Analogue Scale.(Baseline, 2 hours)
  • Change in Self-rated severety of the task on the QbTest assessed by a Visual Analogue Scale.(Baseline, 2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lennart Jansson

PhD RegPsychologist

Region Västmanland

研究点 (1)

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