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Effects of expectations, medication and placebo during the Quantified Behavior Test in patients with untreated ADHD and Substance Use Disorder

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 Disorder

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-001488-11-SE
Enrollment
Unknown
Registered
2014-12-16
Start date
2015-03-18
Completion date
Unknown
Last updated
2015-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

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- Phar

Sponsors

Landstinget Västmanland
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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. 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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.;Secondary Objective: not applicable;Primary end point(s): Primary outcome variables are the weghted summary parameters QbActivity, QbInattention and QbImpulsivity on the Qb Test plus.;Timepoint(s) of evaluation of this end point: December 2015—

Secondary

MeasureTime frame
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. ;Timepoint(s) of evaluation of this end point: December 2015—

Countries

Sweden

Contacts

Public ContactBlanca Domingo

Landstinget Västmanland

blanca.domingo.arnaiz@ltv.se004621175931

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026