Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance
NCT ID: NCT02477280
Last Updated: 2023-05-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
39 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-09-30
Study Completion Date
2021-06-17
Brief Summary
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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.
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.
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Detailed Description
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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).
Patients with substance syndrome often have other expectations for the drug compared to patients with other diagnoses. 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 and substance Use Disorders.
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 computer 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.
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).
Patients with substance syndrome often have other expectations for the drug compared to patients with other diagnoses. 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 and substance Use Disorders.
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 computer 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.
Conditions
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Attention Deficit Hyperactivity Disorder
Substance Use Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Methylphenidate
Methylphenidate 20 mg Tablet single-dose per os
Group Type
EXPERIMENTAL
Methylphenidate
Intervention Type
DRUG
Cross-over
Placebo
Intervention Type
DRUG
Medikinet
Placebo
Placebo 20 mg Tablet single-dose per os
Group Type
PLACEBO_COMPARATOR
Methylphenidate
Intervention Type
DRUG
Cross-over
Placebo
Intervention Type
DRUG
Medikinet
Interventions
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Methylphenidate
Cross-over
Intervention Type
DRUG
Placebo
Medikinet
Intervention Type
DRUG
Other Intervention Names
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Medikinet
Medikinet
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Region Västmanland
OTHER
Sponsor Role
lead
Responsible Party
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Lennart Jansson
PhD RegPsychologist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Lennart Jansson, PhD
Role: PRINCIPAL_INVESTIGATOR
Region Västmanland
Locations
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Landstinget Västmanland
Västerås, , Sweden
Site Status
Countries
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Sweden
References
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Adler LA. Clinical presentations of adult patients with ADHD. J Clin Psychiatry. 2004;65 Suppl 3:8-11.
Reference Type
BACKGROUND
Adler LA, Chua HC. Management of ADHD in adults. J Clin Psychiatry. 2002;63 Suppl 12:29-35.
Reference Type
BACKGROUND
Arias AJ, Gelernter J, Chan G, Weiss RD, Brady KT, Farrer L, Kranzler HR. Correlates of co-occurring ADHD in drug-dependent subjects: prevalence and features of substance dependence and psychiatric disorders. Addict Behav. 2008 Sep;33(9):1199-207. doi: 10.1016/j.addbeh.2008.05.003. Epub 2008 May 13.
Reference Type
BACKGROUND
Bernardi S, Faraone SV, Cortese S, Kerridge BT, Pallanti S, Wang S, Blanco C. The lifetime impact of attention deficit hyperactivity disorder: results from the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). Psychol Med. 2012 Apr;42(4):875-87. doi: 10.1017/S003329171100153X. Epub 2011 Aug 16.
Reference Type
BACKGROUND
Bijlenga D, Jasperse M, Gehlhaar SK, Sandra Kooij JJ. Objective QbTest and subjective evaluation of stimulant treatment in adult attention deficit-hyperactivity disorder. Eur Psychiatry. 2015 Jan;30(1):179-85. doi: 10.1016/j.eurpsy.2014.06.003. Epub 2014 Aug 27.
Reference Type
BACKGROUND
Bingel U, Wanigasekera V, Wiech K, Ni Mhuircheartaigh R, Lee MC, Ploner M, Tracey I. The effect of treatment expectation on drug efficacy: imaging the analgesic benefit of the opioid remifentanil. Sci Transl Med. 2011 Feb 16;3(70):70ra14. doi: 10.1126/scitranslmed.3001244.
Reference Type
BACKGROUND
Colloca L, Klinger R, Flor H, Bingel U. Placebo analgesia: psychological and neurobiological mechanisms. Pain. 2013 Apr;154(4):511-514. doi: 10.1016/j.pain.2013.02.002. Epub 2013 Feb 13. No abstract available.
Reference Type
BACKGROUND
Edebol H; Helldin L; Holmberg E; Gustafsson S-A; Norlander T. In search for objective measures of hyperactivity, impulsivity and inattention in adult attention deficit hyperactivity disorder using the Quantified Behavior Test Plus. Europe´s Journal of Psychology 2011, 7, 443-457.
Reference Type
BACKGROUND
Edebol H, Helldin L, Norlander T. Objective Measures of Behavior Manifestations in Adult ADHD and Differentiation from Participants with Bipolar II Disorder, Borderline Personality Disorder, Participants with Disconfirmed ADHD as Well as Normative Participants. Clin Pract Epidemiol Ment Health. 2012;8:134-43. doi: 10.2174/1745017901208010134. Epub 2012 Nov 2.
Reference Type
BACKGROUND
Edebol H, Helldin L, Norlander T. The weighed core symptom scale and prediction of ADHD in adults - objective measures of remission and response to treatment with methylphenidate. Clin Pract Epidemiol Ment Health. 2013 Oct 18;9:171-9. doi: 10.2174/1745017901309010171. eCollection 2013.
Reference Type
BACKGROUND
Enck P, Bingel U, Schedlowski M, Rief W. The placebo response in medicine: minimize, maximize or personalize? Nat Rev Drug Discov. 2013 Mar;12(3):191-204. doi: 10.1038/nrd3923.
Reference Type
BACKGROUND
Ginsberg Y, Hirvikoski T, Grann M, Lindefors N. Long-term functional outcome in adult prison inmates with ADHD receiving OROS-methylphenidate. Eur Arch Psychiatry Clin Neurosci. 2012 Dec;262(8):705-24. doi: 10.1007/s00406-012-0317-8. Epub 2012 Apr 21.
Reference Type
BACKGROUND
Harrison AG, Edwards MJ, Parker KC. Identifying students faking ADHD: Preliminary findings and strategies for detection. Arch Clin Neuropsychol. 2007 Jun;22(5):577-88. doi: 10.1016/j.acn.2007.03.008. Epub 2007 May 15.
Reference Type
BACKGROUND
Linde K, Fassler M, Meissner K. Placebo interventions, placebo effects and clinical practice. Philos Trans R Soc Lond B Biol Sci. 2011 Jun 27;366(1572):1905-12. doi: 10.1098/rstb.2010.0383.
Reference Type
BACKGROUND
Lis S, Baer N, Stein-en-Nosse C, Gallhofer B, Sammer G, Kirsch P. Objective measurement of motor activity during cognitive performance in adults with attention-deficit/hyperactivity disorder. Acta Psychiatr Scand. 2010 Oct;122(4):285-94. doi: 10.1111/j.1600-0447.2010.01549.x. Epub 2010 Feb 25.
Reference Type
BACKGROUND
McGough JJ, Barkley RA. Diagnostic controversies in adult attention deficit hyperactivity disorder. Am J Psychiatry. 2004 Nov;161(11):1948-56. doi: 10.1176/appi.ajp.161.11.1948.
Reference Type
BACKGROUND
Meissner K, Bingel U, Colloca L, Wager TD, Watson A, Flaten MA. The placebo effect: advances from different methodological approaches. J Neurosci. 2011 Nov 9;31(45):16117-24. doi: 10.1523/JNEUROSCI.4099-11.2011.
Reference Type
BACKGROUND
Nylander L, Holmqvist M, Gustafson L, Gillberg C. ADHD in adult psychiatry. Minimum rates and clinical presentation in general psychiatry outpatients. Nord J Psychiatry. 2009;63(1):64-71. doi: 10.1080/08039480802416323.
Reference Type
BACKGROUND
Ohlmeier MD, Peters K, Te Wildt BT, Zedler M, Ziegenbein M, Wiese B, Emrich HM, Schneider U. Comorbidity of alcohol and substance dependence with attention-deficit/hyperactivity disorder (ADHD). Alcohol Alcohol. 2008 May-Jun;43(3):300-4. doi: 10.1093/alcalc/agn014. Epub 2008 Mar 7.
Reference Type
BACKGROUND
Pelham WE; Lang AR. Parental alcohol consumption and deviant child beha-vior: Laboratory studies of reciprocal effects. Clinical Psychology Review 1993, 13, 763-784.
Reference Type
BACKGROUND
Rasmussen K, Levander S. Untreated ADHD in adults: are there sex differences in symptoms, comorbidity, and impairment? J Atten Disord. 2009 Jan;12(4):353-60. doi: 10.1177/1087054708314621. Epub 2008 Mar 26.
Reference Type
BACKGROUND
Sullivan MA, Rudnik-Levin F. Attention deficit/hyperactivity disorder and substance abuse. Diagnostic and therapeutic considerations. Ann N Y Acad Sci. 2001 Jun;931:251-70. doi: 10.1111/j.1749-6632.2001.tb05783.x.
Reference Type
BACKGROUND
Soderstrom S, Pettersson R, Nilsson KW. Quantitative and subjective behavioural aspects in the assessment of attention-deficit hyperactivity disorder (ADHD) in adults. Nord J Psychiatry. 2014 Jan;68(1):30-7. doi: 10.3109/08039488.2012.762940. Epub 2013 Mar 26.
Reference Type
BACKGROUND
Torgersen T, Gjervan B, Rasmussen K. ADHD in adults: a study of clinical characteristics, impairment and comorbidity. Nord J Psychiatry. 2006;60(1):38-43. doi: 10.1080/08039480500520665.
Reference Type
BACKGROUND
van Emmerik-van Oortmerssen K, van de Glind G, van den Brink W, Smit F, Crunelle CL, Swets M, Schoevers RA. Prevalence of attention-deficit hyperactivity disorder in substance use disorder patients: a meta-analysis and meta-regression analysis. Drug Alcohol Depend. 2012 Apr 1;122(1-2):11-9. doi: 10.1016/j.drugalcdep.2011.12.007. Epub 2011 Dec 30.
Reference Type
BACKGROUND
Whalen CK, Henker B. Psychostimulants and children: a review and analysis. Psychol Bull. 1976 Nov;83(6):1113-30. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
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2014-001488-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2015-03-10/11
Identifier Type: -
Identifier Source: org_study_id
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A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.
NCT00246220
COMPLETED
PHASE3
Benefits of ADHD Treatment in Detained People
NCT05842330
RECRUITING
PHASE3
Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial
NCT05200936
COMPLETED
PHASE2
Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
NCT00152022
COMPLETED
PHASE3
Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA
NCT00730249
COMPLETED
PHASE3
Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder
NCT04170738
COMPLETED
PHASE4
Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?
NCT01127607
COMPLETED
PHASE4
Treatment of Patients With Alcoholism and Attention Deficit Disorder
NCT00261872
COMPLETED
PHASE4
Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder
NCT00877487
COMPLETED
PHASE4
Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder
NCT00223561
COMPLETED
PHASE4
Does Active Parent Involvement in Deliberation and Choice Improve Medication Persistence for Their Child With ADHD
NCT00631280
COMPLETED
NA
Adult Attention Deficit Hyperactivity Disorder
NCT01692782
COMPLETED
PHASE2
Methylphenidate in Healthy Young Adults
NCT00815841
UNKNOWN
PHASE4
Influence of Stimulant Medication on Brain Processes for Decision Making in Attention Deficit Hyperactivity Disorder
NCT01831622
COMPLETED
PHASE4
Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children
NCT00183391
COMPLETED
PHASE4
Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill
NCT05243186
UNKNOWN
PHASE2/PHASE3