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

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.
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2014-001488-11-SE

Lead Sponsor: andstinget Västmanland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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