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| Name | Class |
|---|---|
| Finzelberg GmbH | INDUSTRY |
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The aim of this study is to investigate the effects of 15 mg/kg lemon verbena, in comparison to placebo, on the attention deficit hyperactivity disorder (ADHD) type behaviour and cognitive function of children who do not have a diagnosis of ADHD, but who exhibit high scores (highest tertile) on ADHD behaviour parameters. Multiple aspects of mood will also be assessed.
The proposed randomised, double-blind, placebo-controlled, parallel groups design methodology will assess the psychological effects of 15 mg/kg lemon verbena extract and a matched placebo prior to and after 4 and 8 weeks of supplementation. The trial will utilise the COMPASS cognitive assessment system (Northumbria University) and a range of mood measures during laboratory testing visits.
Parents and children will also take part in a concomitant smartphone study, comprising the collection of the parent's assessment of the child's behaviour/cognitive function and the child's self-report of the same, plus their mood. These assessments will take place on Days -1, 14, 28, 42 and 56.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lemon verbena | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lemon verbena | Dietary Supplement | Lemon verbena supplement administered at an estimated daily dose of 15mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Conners 3 score from baseline to 8 weeks, parent rating | Baseline to 8 weeks | |
| Change in Conners 3 score from baseline to 8 weeks, child rating | Baseline to 8 weeks | |
| Change in total mood disturbance from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks |
| Change in depression-dejection from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks |
| Change in tension-anxiety from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks |
| Change in anger-hostility from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks |
| Change in confusion-bewilderment from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks |
| Change in vigour-activity from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks |
| Change in fatigue-inertia from baseline to 8 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippa Jackson, PhD | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain, Performance, Nutrition Research Centre, Northumbria University | Newcastle upon Tyne | Tyne & Wear | NE1 8ST | United Kingdom |
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| ID | Term |
|---|---|
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Placebo | Dietary Supplement | Placebo supplement containing carrier material only |
|
Profile of mood states questionnaire |
| Baseline to 8 weeks |
| Change in systolic blood pressure from baseline to 8 weeks | Systolic blood pressure (mmHg) | Baseline to 8 weeks |
| Change in diastolic blood pressure from baseline to 8 weeks | Diastolic blood pressure (mmHg) | Baseline to 8 weeks |
| Change in body temperature from baseline to 8 weeks | Degrees Celsius | Baseline to 8 weeks |
| Change in RMSSD during the performance of cognitive tasks from baseline to 8 weeks | Root mean square of successive differences between normal heartbeats (RMSSD) | Baseline to 8 weeks |
| Change in heart rate during the performance of cognitive tasks from baseline to 8 weeks | Beats per minute | Baseline to 8 weeks |
| Change in heart rate variability index during the performance of cognitive tasks from baseline to 8 weeks | Heart rate variability index | Baseline to 8 weeks |
| Change in pNN50 during the performance of cognitive tasks from baseline to 8 weeks | pNN50 is the mean number of times per hour in which the change in consecutive normal sinus (NN) intervals exceeds 50 milliseconds. | Baseline to 8 weeks |
| Change in stress index during the performance of cognitive tasks from baseline to 8 weeks | The stress index is a measure of the ratio between the parasympathetic and sympathetic tone. intervals exceeds 50 milliseconds. | Baseline to 8 weeks |
| Change in subjective anxiety from baseline to 8 weeks | State-trait anxiety inventory (STAI) total score | Baseline to 8 weeks |
| Change in subjective perceived stress from baseline to 8 weeks | Perceived stress scale (PSS) total score | Baseline to 8 weeks |
| Change in subjective mood from baseline to 8 weeks, alertness | Visual analogue scale composite score | Baseline to 8 weeks |
| Change in subjective mood from baseline to 8 weeks, stress | Visual analogue scale composite score | Baseline to 8 weeks |
| Change in subjective mood from baseline to 8 weeks, tranquility | Visual analogue scale composite score | Baseline to 8 weeks |
| Change in speed of performance from baseline to 8 weeks | Cognitive task composite score, milliseconds | Baseline to 8 weeks |
| Change in accuracy of performance from baseline to 8 weeks | Cognitive task composite score, % | Baseline to 8 weeks |
| Change in accuracy of performance on arrow flankers task from baseline to 8 weeks | Cognitive task score, % | Baseline to 8 weeks |
| Change in accuracy of performance on numeric working memory task from baseline to 8 weeks | Cognitive task score, % | Baseline to 8 weeks |
| Change in accuracy of performance on Stroop task from baseline to 8 weeks | Cognitive task score, % | Baseline to 8 weeks |
| Change in accuracy of performance on Corsi blocks task from baseline to 8 weeks | Cognitive task score, % | Baseline to 8 weeks |
| Change in accuracy of performance on rapid visual information processing task from baseline to 8 weeks | Cognitive task score, % | Baseline to 8 weeks |
| Change in accuracy of performance on peg and ball task from baseline to 8 weeks | Cognitive task score, number of errors | Baseline to 8 weeks |
| Change in reaction time of performance on arrow flankers task from baseline to 8 weeks | Cognitive task score, reaction time in milliseconds | Baseline to 8 weeks |
| Change in reaction time of performance on numeric working memory task from baseline to 8 weeks | Cognitive task score, reaction time in milliseconds | Baseline to 8 weeks |
| Change in reaction time of performance on Stroop task from baseline to 8 weeks | Cognitive task score, reaction time in milliseconds | Baseline to 8 weeks |
| Change in reaction time of performance on rapid visual information processing task from baseline to 8 weeks | Cognitive task score, reaction time in milliseconds | Baseline to 8 weeks |
| Change in false alarms on rapid visual information processing task from baseline to 8 weeks | Cognitive task score, number of false alarms | Baseline to 8 weeks |
| Change in completion time of peg and ball task from baseline to 8 weeks | Cognitive task score, time in milliseconds | Baseline to 8 weeks |
| Change in thinking time of peg and ball task from baseline to 8 weeks | Cognitive task score, time in milliseconds | Baseline to 8 weeks |