Effects of expectations, medication and placebo on objective and self-rated performance during the Quantified Behavior Test in terms of the ADHD core signs hyperactivity, inattention and impulsivity in patiens with untreated ADHD.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2014
INTERVENTION: Trade Name: Medikinet Pharmaceutical Form: Tablet INN or Proposed INN: METHYLPHENIDATE CAS Number: 113‐45‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Effects of expectations, medication and placebo on objective and self‐rated performance during the Quantified Behavior Test in terms of the ADHD core signs hyperactivity, inattention and impulsivity in patients with untreated ADHD. Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: Main Objective: To examine the effects of expectations, medication and placebo on objective and self‐rated performance on ADHD core signs during the Quantified Behavior Test. Primary end point(s): Primary outcom variables are the weighted summary parameters QbActivity, QbInattention and QbImpulsivity on the Qb Test plus. Secondary Objective: Not applicable. Timepoint(s) of evaluation of this end point: December 2016 SECONDARY OUTCOME: Secondary end point(s): Secondary outcom variables are self‐rated scales concerning expected and experienced performance on the Qb Test, help from the pill, and perceived severity on the task. Timepoint(s) of evaluation of this end point: December 2016 INCLUSION CRITERIA: 1. 18 years old or older. 2. ADHD is diagnosed according to DSM‐5 criteria. 3. Qb‐score 1.3 or higher on any of the weighted summary parameters QbActivity, QbInAttention or QbImpulsivity on the QbTest. 4. Patiens are given their written informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 25ed35fd197ca60a4af3d689805200ee422df179
First added on: Aug 23, 2024