Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the QbTest

NCT02473185 | Completed Phase 4 DMC

• 2 other identifiers: 2015-03-10/532014-005045-53
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Weighted summary parameter QbInattention score on the QbTest.

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

  Baseline, 2 hours

Secondary Outcomes (7)

• Change in Weighted summary parameter QbActivity score on the QbTest.

  Baseline, 2 hours

• Change in Weighted summary parameter QbImpulsivity score on the QbTest.

  Baseline, 2 hours

• Change in Self-rated expected performance.

  Baseline, 2 hours

• Change in Self-rated mental effort

  Baseline, 2 hours

• Change in Self-rated severity of the task

  Baseline, 2 hours

Study Arms (2)

Methylphenidate

EXPERIMENTAL

Methylfenidate 20 mg Tablet single-dose per os

Drug: Methylphenidate

Placebo

PLACEBO COMPARATOR

Placebo 20 mg Tablet single-dose per os

Drug: Methylphenidate

Interventions

Methylphenidate DRUG

Cross-over

Also known as: Medikinet

Methylphenidate; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 Medicinet pill.
• Concurrent clinical diagnosis that significantly could affect test performance.
• Concurrent prescription of medicines for ADHD or medicines that significantly could affect test performance.

Sponsors & Collaborators

• Region Västmanland: lead

Study Sites (1)

Landstinget Västmanland

Västerås, SE-72189, Sweden

Location

Related Publications (23)

• Adler LA. Clinical presentations of adult patients with ADHD. J Clin Psychiatry. 2004;65 Suppl 3:8-11.

  PMID: 15046529 BACKGROUND

• Adler LA, Chua HC. Management of ADHD in adults. J Clin Psychiatry. 2002;63 Suppl 12:29-35.

  PMID: 12562059 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.

  PMID: 25172155 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.

  PMID: 21325618 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.

  PMID: 23473783 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.

  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.

  PMID: 23166565 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.

  PMID: 24265648 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.

  PMID: 23449306 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.

  PMID: 22526730 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.

  PMID: 17507198 BACKGROUND

• Knagenhjelm P; Ulberstad F. Qb Test Technical Manual. Stockholm: Qbtech AB 2010.

  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.

  PMID: 21576148 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.

  PMID: 20199487 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.

  PMID: 15514392 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.

  PMID: 22072664 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.

  PMID: 18991159 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.

  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.

  PMID: 18367759 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.

  PMID: 23527787 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.

  PMID: 16500798 BACKGROUND

• Whalen CK, Henker B. Psychostimulants and children: a review and analysis. Psychol Bull. 1976 Nov;83(6):1113-30. No abstract available.

  PMID: 792938 BACKGROUND

• Jansson L, Lohman M, Ostlund M, Domingo B. Effects of one single-dose methylphenidate compared to one single-dose placebo on QbTest performance in adults with untreated ADHD: a randomized controlled trial. BMC Psychiatry. 2023 Oct 17;23(1):762. doi: 10.1186/s12888-023-05231-8.

  PMID: 37848887 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lennart Jansson, PhD

  Region Västmanland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Reg Psychologist

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)