The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Inclusion Criteria: 1. Children/adolescents aged 6-18 diagnosed with ADHD as per DSM-V by a neurologist, psychiatrist or other specialist. 2. Willing/able to arrive to all the necessary visits as per study protocol. Exclusion Criteria: 1. Participants who used ADHD conventional medications in the month before starting the study or intend to do so during the study. 2. Participants who used benzodiazepines or first-generation antihistamines in the week before starting the study or other drugs which may interfere with the study as per PI opinion. 3. Participants suffering from neurological or psychiatric diseases. 4. Participants suffering from neoplastic diseases. 5. Participants with syndromes or metabolic diseases. 6. Participants with a significant clinic diagnosis which may interfere with the study. May be included later on as per PI opinion. 7. Pregnant or breastfeeding adolescents. 8. Sexually active female adolescents who are unwilling to use contraceptives. 9. Participants that in the PI opinion will not comply with the protocol in a way that will harm the study (for ex.: not using contraceptives.) 10. Participants with less than 18 kg or more than 90 kg weight. 11. Participants with BMI lower than 18 or higher than 29.9. 12. Participants engaged in another clinical study which includes a medicine. 13. Participants engaged in another study regarding ADHD treatment of any kind. 14. Participants using alcohol or drugs. 15. Past or present use of Cannabis, including medical cannabis Criteria for early termination: 1. Use of another medication for ADHD during the study. 2. Use of a medication from the exclusion criteria list during the study. 3. Use of alcohol or drugs during the study. 4. Participants who got pregnant during the study. 5. Participants who split the first visit and did not arrive to the second part of the first visit after a maximum of 28 days. 6. Participants who did not start the treatment during the 14 days from receiving the drug. 7. Non -compliant participants. Criteria for exchange: 1. PI may exchange participants that quit, if they did not start treatment for new participants. 2. PI may recruit again participants who quit after a new full recruitment process.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in hyperactivity sub-score of the Conners' Parent Questionnaire, as compared with baseline.;Improvement in inattentiveness sub-score of the Conners' Parent Questionnaire, as compared with baseline.

Secondary Outcome Measures

Name	Time	Method
Improvement in Conners' Parent Questionnaire - Total score, as compared with baseline.;Improvement in hyperactivity sub-score of the TOVA test, as compared with baseline.;Improvement in inattentiveness sub-score of the TOVA test, as compared with baseline.;Improvement in TOVA test - Total score, as compared with baseline.;Improvement in hyperactivity sub-score of the Conners' Teacher Questionnaire, as compared with baseline.;Improvement in inattentiveness sub-score of the Conners' Teacher Questionnaire, as compared with baseline;Improvement in Conners' Teacher Questionnaire - Total score, as compared with baseline.;Improvement in the scores of CBCL questionnaire, as compared with baseline.;Side effects are tolerable and transient.;The rate of drop-out will be similar in both groups.