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

• Status: Recruiting
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Landstinget Västmanland; Region Västmanland
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 18 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.

Exclusion Criteria:

• 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.