The effectiveness of L-theanine-caffeine combination given as a supplement compared to methylphenidate and placebo on improvement of selective attention in adolescents (age 10-19 years old) with attention-deficit hyperactive disorder: a double-blind, 3-way crossover trial
- Conditions
- Attention deficit hyperactive disorder
- Registration Number
- SLCTR/2023/004
- Lead Sponsor
- Faculty of Medicine, University of Peradeniya.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 42
Participants must meet all of the inclusion criteria given in order to be eligible to participate in the study
1. Patients diagnosed with attention deficit hyperactive disorder by a psychiatrist.
2. 10-19 years old, boys and girls
3. Patients who have responded to methylphenidate.
4. Normal, or corrected-to-normal vision and normal hearing.
All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation
1.Gross impairment of vision or hearing that would prevent the participants from performing neuropsychological tasks
2.Inability to read and follow written instructions
3.Physical, neurological or concurrent psychiatric impairments (except ADHD) that could affect cognitive and motor functions
4.Intake of psychoactive substances which have the potential to affect cognitive functions and those which may interact with caffeine (other than their medications for ADHD)
5.Current / past diagnosis of tics or other forms of dyskinesia
6.Regular intake of medication that could alter visual, auditory, cognitive or motor functions (except stimulants)
7.History of head injury that resulted in loss of consciousness / history of brain surgery
8.Intake of drugs containing caffeine, other phosphodiesterase inhibitors or adenosine receptor blockers within the past 3 months
9.Intake of medications which are known to have pharmacological interactions with caffeine within the past 3 months
10.History of development of headache, drowsiness, anxiety, insomnia or nausea following intake of caffeine or caffeine containing beverages
11.Current / past history of smoking and / or alcohol or drug abuse
12.Unwillingness or inability to entirely refrain from use of electronic devices during study visits
13.Unwillingness or inability to refrain from intake of L-theanine and caffeine containing food or beverages within the 24 hours prior to each study visit
14.Unwillingness or inability to follow written, on-screen and verbal instructions given by the study team
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method