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

NCT02477280 | Completed Phase 4 DMC

• 2 other identifiers: 2015-03-10/112014-001488-11
• Study Type: interventional
• Target: 39
• 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 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.

Conditions

Attention Deficit Hyperactivity Disorder; Substance Use 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 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 Self-rated severety of the task on the QbTest assessed by a Visual Analogue Scale.

  Baseline, 2 hours

Study Arms (2)

Methylphenidate

EXPERIMENTAL

Methylphenidate 20 mg Tablet single-dose per os

Drug: Methylphenidate; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo 20 mg Tablet single-dose per os

Drug: Methylphenidate; Drug: Placebo

Interventions

Methylphenidate DRUG

Cross-over

Also known as: Medikinet

Methylphenidate; Placebo

Placebo DRUG

Medikinet

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 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.

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 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.

Sponsors & Collaborators

• Region Västmanland: lead

Study Sites (1)

Landstinget Västmanland

Västerås, SE-72189, Sweden

Location

Related Publications (26)

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MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Substance-Related Disorders

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Chemically-Induced 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 RegPsychologist

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 22, 2015
• Study Start: September 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: June 17, 2021
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)