NCT02477280

Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the Quantified Behavior Test in Patients With Untreated ADHD and Substance Use Disorder

Completed Phase 4 Last updated 3 May 2023

What this trial tests

Phase 4 trial testing Methylphenidate in Attention Deficit Hyperactivity Disorder in 39 participants. Completed in 17 June 2021.

Timeline

1 September 2016

Primary endpoint
1 June 2021

17 June 2021

Quick facts

Lead sponsor	Region Västmanland
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	basic science
Enrollment	39
Start date	1 September 2016
Primary completion	1 June 2021
Estimated completion	17 June 2021
Sites	1 location across Sweden

Drugs / interventions tested

• Methylphenidate (methylphenidate) — full drug profile →
• Placebo

Conditions studied

• Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →
• Substance Use Disorder — all drugs for Substance Use Disorder →

Sponsor

Region Västmanland

Who can join

Adults 18 to 60, any sex, with Attention Deficit Hyperactivity Disorder or Substance Use Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Weighted summary parameter QbInattention score on the QbTest.
  Time frame: Baseline, 2 hours
  Evaluating change in weighted summary parameter QbInattention score on the QbTest.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults.
   Cândido RCF, Menezes de Padua CA, Golder S, Junqueira DR. · · 2021 · cited 17× · PMID 33460048 · DOI 10.1002/14651858.cd013011.pub2