The Continuous Performance Test (CPT) study: OROS-methylphenidate efficacy on objective measures

Not Applicable

Completed

• Conditions: Attention Deficit/Hyperactivity Disorder; Mental and Behavioural Disorders; Disturbance of activity and attention

• Registration Number: ISRCTN52392534
• Lead Sponsor: Parnassia Bavo Academy (PBA) (Netherlands)

Brief Summary

2014 results in https://www.ncbi.nlm.nih.gov/pubmed/24508533 (added 09/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-02-11
• Study Start: 2013-07-02
• Last Update Posted: 2 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Between 18-55 years of age. The participants are of either sex. We included 22 adults with the combined subtype of ADHD, of which 17 were male and 5 were female.
2. Diagnosis of ADHD, combined subtype

Exclusion Criteria

1. Having severe comorbid psychiatric disorders at time of the study screening (as measured by the Structured Clinical Interview for DSM disorders; SCID)
2. Receiving treatment with stimulants, antipsychotics, clonidine, benzodiazepines, or beta-blockers <1 month before study participation
3. Having any cognitive disorder like dementia or amnesic disorder
4. Mental retardation
5. Being pregnant or nursing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Objective efficacy of medication on five parameters of the Conner?s Continuous Performance Test (C-CPT) and Test of Variables of Attention (TOVA): Hit Reaction Time (HRT), Reaction Time Variability (RTV), Omission Errors (OE), Commission Errors (CE), and D-Prime (DP).<br><br> The primary outcomes were measured at baseline, after using 72mg of placebo medication, and after using 72mg of OROS-methylphenidate, that is, at the end of week 1, week 3 and week 6.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Subjective efficacy as measured by the number of ADHD symptoms using the ADHD-Rating scale<br> 2. Adherence to medication using the Adherence Questionnaire<br> 3. Side effects of medication using the Side Effects Rating Scale<br><br> The secondary outcomes were tested every week in order to monitor the well-being and adherence of the participants, but only considered for analyses in week 1, week 3 and week 6 (i.e., at baseline, after using 72mg of placebo medication, and after using 72mg of OROS-methylphenidate).<br>