Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the Quantified Behavior Test in Patients With Untreated ADHD
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.
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 the other half of the participants receive placebo first. Neither the participant
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.
The Quantized Behavior Test (QbTest) can be included as part of an neuropsychiatric
investigation. QbTest measures the three core signs of ADHD, hyperactivity, inattention and
impulsivity. QbTest is a computer-based test that combines a test of attention ability with a
movement analysis based on an infrared measurement system. The test results are presented in
a report and compared with norm data fromm a group of the same sex amd age who do not have
ADHD.
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).
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).
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). Some of these patients have often learned
to deal with awkward and difficult life situations using drugs (Whalen & Henker 1976; Pelham
& Lang 1993). This may increases the risk that the person receives a low confidence in their
own ability to solve critical situations without drugs. Therefore, it is important to
identify those patients in order to give them a treatment specialized to their need.
This study intends to investigate whether the patient's expectation of their own ability to
solve problems increases when they take a drug.
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.
This leads to the following questions ;
1. Does the participant's self-rated expectation of future performance change in the
presence of active drug or placebo?
2. Does the participant's self-rated performance change in the presence of active drug or
placebo?
3. Does the participant's perception of exertion change in the presence of active drug or
placebo?
4. Does the participant's performance on the core signs, Hyperactivity, Inattention and
Impulsivity on the QbTest change in the presence of active drug or placebo ?
5. Does the participant's experience of the tablet's efficacy change in the presence of
active drug or placebo?
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.
Subjects Participants are 40 consecutive patients remitted to a neuropsychiatric
investigation at the Dependence Clinic Västmanland, Västerås, Sweden.
Instruments The Quantized Behavior Test (QbTest) can be included as part of an
neuropsychiatric investigation. QbTest measures the three core signs of ADHD, hyperactivity,
inattention and impulsivity.
The QbTest combines a Continuous Performance Test (CPT) installed as a software program on a
PC with measures of attention and impulsivity and an activity test with measures of
motor-activity during 20 minutes. While performing the CPT-test on the computer, movements of
the participant are recorded using an infrared camera following a reflective marker attached
to a head-band. The CPT-test involves rapid presentations of figures with various shapes
(square or circle) and colors (red or blue) and the participant are instructed to press a
handheld button when a stimuli subsequently repeats itself (a target) and not to press the
button when the stimulus varies relative to the previous one (a non-target). The stimuli are
presented at a pace of one per two seconds, each one visible for 200 milliseconds, and the
total number of stimuli is 600, presented with a 25% target probability (Knagenhjelm &
Ulberstad 2010).
The clinical documentation for QbTest is extensive. Lis et al demonstrated that patients with
ADHD were significantly different in the variables of attention and activity from a control
group of healthy individuals (Lis et al 2010). Edebol showed that QbTest has a sensitivity of
83 % and a specificity of 57% to detect ADHD in adults (Edebol et al 2011).
The discriminative validity was tested and the results show that QbTest differ not only
between those with ADHD and healthy controls , but between clients with ADHD and other
clinical groups (Söderström, Pettersson & Nilsson 2014; Edebol, Helldin & Norlander 2012).
QbTest has also shown good results as an objective method for monitoring drug treatment with
methylphenidate (Ginsberg, Hirvikoski & Grann 2012; Edebol, Helldin & Norlander 2013;
Bijlenga & Henker 2014).
The Quick Test measure processing speed and automaticity of naming shapes and colours,
Cognitive shifts between visual dimensions and semantic fields and Activation of working
memory for processing and monitoring. AQT's objective measures are based on clocked
total-naming time. Highly reliable (r = .88 - 96) over time and consistent over repeated
trials.
Procedure 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 the other half of the participants receive placebo first.
Neither the participant 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.
Analyses In this study, hyperactivity has been operationalized with the parameter called
"distance", i.e., the length of the path in metres describing the movement of the headband
reflector during the test period. Inattention is operationalized on the basis of omission
errors. An omission error occurs when no response is registered when the stimulus was a
Target, i.e. the button was not pressed when it should have been. Impulsivity is
operationalized on the bases of commission errors. A commission error occurs when a response
is registered when the stimulus was a Non-Target, i.e. the handheld button is pressed when it
should not have been pressed.
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