E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 and Substance Use Disorders. |
Effekten av förväntning, aktivt läkemedel och placebo på objektiv och självskattad prestation vid Qb-test avseende ADHD kärnsymtomen hyperaktivitet, ouppmärksamhet och impulsivitet hos patienter med obehandlad ADHD och substanssyndrom. |
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E.1.1.1 | Medical condition in easily understood language |
Effects of expectations, medication and placebo during the Quantified Behavior Test in patients with untreated ADHD and Substance Use Disorders. |
Effekten av förväntning, läkemedel och placebo på objektiv och självskattad prestation vid Qb-test hos patienter med obehandlad ADHD och substanssyndrom. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To examine the effects of expectations, medication and placebo on objective and self-rated performance on ADHD core signs during the Quantified Behavior Test. |
Att undersöka effekterna av förvänting, läkemedel och placebo på objektiv och självskattad prestation på ADHD kärnsymtom vid Qb-test. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 18 years old or older.
2. ADHD is diagnosed according to DSM-5 criteria.
3. Substance use disorder is diagnosed according to DSM-5 criteria.
4. Qb-score 1.3 or higher on any of the weighted summary parameters QbActivity, QbInAttention or QbImpulsivity on the
Qb Test.
5. Patients are given their written informed consent to participate in the study. |
1. 18 år eller äldre.
2. ADHD diagnos enligt DSM-5 kriterier.
3. Substanssyndrom enligt DSM-5 kriterier.
4. Qb-poäng 1,3 eller högre på någon av de viktade parametrarna QbAktivitet, QbUppmärksamhet och QbImpulsivitet.
5. Patienterna har lämnat skriftligt medgivande att delta i studien. |
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E.4 | Principal exclusion criteria |
1. Affected by alcohol or drugs during the last month.
2. Untreted severe comorbid psychiatric or somatic illness.
3. Bloodpressure 150/95 or higher.
4. Irregular pulse, or pulse 100 or higher.
5. No counter indications according to the Medikinet pill.
6. Concurrent clinical diagnossi that significantly could affect test performance.
7. Concurrent prescription medicines for ADHD or medicines that significantly could affect test performance. |
1. Påverkand av alkohol eller droger under den senaste månaden.
2. Obehandlad svår samsjuklighet, psykiatrisk eller somatisk sjukdom.
3. Blodtryck höger eller lika med 150/95.
4. Oregelbunden puls, eller puls högre eller lika med 100.
5. Inga kontraindikationer till Medikinet.
6. Samtidig klinisk diagnos som signifikant kan påverka testresultatet.
7. Samtidig förskrivning ADHD-medicin eller läkemedel som kan påverka testresultatet. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome variables are the weghted summary parameters QbActivity, QbInattention and QbImpulsivity on the Qb Test plus. |
Primära effektvariabler är de viktade parametrarna QbAktivitet, QbUppmärksamhet och Qbimpulsivitet på Qb Test. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
December 2015 |
December 2015 |
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E.5.2 | Secondary end point(s) |
Secondary outcome variables are self-rated scales concerning expected and experienced performance on the Qb Tes, help from the pill, and perceived severity on the tast. |
Sekundära effektvariabler är självskattningsskalor om förväntad och upplevd prestation på Qb Testet, erhållen hjälp av läkämedel samt upplevd svårighetsgrad på uppgiften. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
December 2015 |
December 2015 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |