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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

Acute effects of L-theanine and caffeine combination on selective attention in adolescents with attention deficit hyperactivity disorder

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2023/004
Enrollment
42
Registered
2023-03-10
Start date
2023-03-11
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Attention deficit hyperactive disorder

Interventions

1.Participants will be selected from child psychiatry outpatient clinics in Teaching Hospital Peradeniya and Sirimavo Bandaranayake Specialized Children Hospital with prior approval from relevant auth

Sponsors

Faculty of Medicine, University of Peradeniya.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Behavioral data Selective visual attention is the primary cognitive domain examined in the proposed experimental study. It will be evaluated by using a visual oddball paradigm developed with two sets of stimuli. Visual stimuli will be presented, and the reactions will be recorded using the Presentation® (Neurobehavioral Systems, Inc. Albany CA) software on a Windows TM-based personal computer. At the end of the test, the Presentation® software will report the following outcome measures. 1. Hits: correct responses to targets (i.e., downward pointing triangle) 2. False alarms: active responses made for triangles 3. Mean hit reaction time: Time from onset of the target stimulus to response. Hits, misses, and false alarms measure the accuracy of the task and hit reaction time measures the speed. [(pre-dose) and 45 minutes after (post-dose) each treatment. ] EEG data A BioSemi Active Two EEG/ERP acquisition system with ActiView software (BioSemi, Amsterdam) will be used to acquire EEG data. A detailed description of this electrode referencing system can be found on the product website: https://www. biosemi.com/faq/cms&drl.htm. Cognitive event-related potentials (ERPs) are derived from the EEG data. ERPs waveforms are neurophysiological measures of attentive processing (P300 component) and pre-attentive processing (N1 component). ERP data: Peak latencies and amplitudes of N1 and P300 ERP components (4 variables) [(pre-dose) and 45 minutes after (post-dose) each treatment.]

Secondary

MeasureTime frame
None []

Countries

Sri Lanka

Contacts

Public ContactDr. N.G.S Nawarathna

Lecturer (probationary)

gayaninawa@dental.pdn.ac.lk081 2397235

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026