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

NCT02473185 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-08-28

No results posted yet for this study

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

Interventions

DRUG

Methylphenidate

Cross-over

Sponsors & Collaborators

  • Region Västmanland

    lead OTHER

Principal Investigators

  • Lennart Jansson, PhD · Region Västmanland

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02473185 on ClinicalTrials.gov