CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 39 enrolled
Drug / intervention
Methylphenidate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02477280
NCT02477280Phase 4Completed

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

Region Västmanland·interventional·Posted Jun 22, 2015·Updated May 6, 2023

In Brief

A Phase 4 clinical trial evaluating Methylphenidate and Placebo for Attention Deficit Hyperactivity Disorder and Substance Use Disorder. Completed, enrolled 39 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 22, 2015
Enrollment StartSep 1, 2016
Primary CompletionJun 1, 2021
Study CompletionJun 17, 2021
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.0 years ago

Interventions

Methylphenidatedrug

Cross-over

Placebodrug

Medikinet