Effects of expectations, medication and placebo during the Quantified Behavior Test in patients with untreated ADHD.
- 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.Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2014-005045-53-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
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
1. Affected by alcohol or drugs during the last month.
2. Untreated 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 diagnosis that significantly could affect test performance.
7. Concurrent prescription of medicines for ADHD or medicines that significantliy 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 outcom variables are the weighted summary parameters QbActivity, QbInattention and QbImpulsivity on the Qb Test plus.;Timepoint(s) of evaluation of this end point: December 2016
- Secondary Outcome Measures
Name Time Method 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