Distúrbio da atividade e da atenção
Conditions
Interventions
This is a randomized, double-blind, placebo-controlled, parallel-arm clinical trial with 60 adolescent participants diagnosed with Attention-Deficit and Hyperactivity Disorder. Participants will be al
Sponsors
Sociedade De Educação Superior e Cultura Brasil S.A.
Associação Brasileira de Cannabis Medicinal (Santa Cannabis)
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: Adolescents of both sexes, aged 12 to 17 years, residing in the Greater Florianópolis region, with a previous diagnosis of attention deficit and hyperactivity disorder confirmed through the SNAP-IV instrument; absence of other severe mental conditions or physical comorbidities; history of previous treatment with other medications without significant improvement of symptoms; agreement to participate in the study through signing of the Informed Consent Form by the legal guardian and the Assent Form by the adolescent
Exclusion criteria
Exclusion criteria: Use of natural or synthetic cannabinoid substances in the month prior to study initiation; history of intolerance to plant components such as confusion, paranoia, pruritus, excessive drowsiness, vomiting, diarrhea or seizures; presence of any physical comorbidities; presence of severe mental disorder not related to the research objective; moderate or severe cognitive impairment; inadequate completion of the study data collection instruments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It’s expected to find change in the severity of Attention-Deficit and Hyperactivity Disorder symptoms over the twelve-week intervention period, measured by variation in scores on the SNAP-IV (Swanson, Nolan and Pelham Questionnaire, version IV) administered during the clinical assessments conducted at baseline, week six, and week twelve | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the quality of life of the participant and the legal guardian are expected to be observed, measured by the Children and Adolescents Quality of Life Questionnaire (KINDL) and the World Health Organization Quality of Life Assessment – Brief Version (WHOQOL-BREF) administered at baseline, week six and week twelve; changes in symptoms of depression, anxiety and stress measured by the DASS-21 (Depression Anxiety and Stress Scale) at the same assessment points; changes in sleep patterns measured by the CSHQ (Child Sleep Habits Questionnaire) administered at the three assessment points; occurrence and intensity of adverse effects related to the use of full spectrum cannabigerol oil recorded through structured clinical interviews conducted during weekly remote monitoring and during in-person clinical assessments throughout the twelve-week intervention | — |
Countries
Brazil
Contacts
Public ContactRafael Bitencourt
Universidade do Sul de Santa Catarina (UNISUL)
Outcome results
None listed