RBR-5dknb4r Use of genetics and artificial intelligence to personalize medical cannabis treatment for anxiety and depression

Date of registration: 04/29/2026 ^(mm/dd/yyyy)
Last approval date : 04/29/2026 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1339-1016

• Public title:

  en

  Use of genetics and artificial intelligence to personalize medical cannabis treatment for anxiety and depression

  pt-br

  Uso de genética e inteligência artificial para personalizar o tratamento com cannabis medicinal em ansiedade e depressão

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 91863025.8.0000.0121
    Issuing authority: Plataforma Brasil
  • 8.289.917
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal de Santa Catarina

Sponsors

• Primary sponsor: Universidade Federal de Santa Catarina
• Secondary sponsor:
  • Institution: Instituto de Ensino e Pesquisa (IEP) Remederi
• Supporting source:
  • Institution: FAPESC

Health conditions

• Health conditions:

  en

  Depressive Disorder; Generalized Anxiety Disorder

  pt-br

  Transtorno Depressivo; Transtorno de Ansiedade Generalizado

• General descriptors for health conditions:

  en

  F03 Mental Disorders

  pt-br

  F03 Transtornos Mentais

• Specific descriptors:

  en

  F03.600.300 Depressive Disorder

  pt-br

  F03.600.300 Transtorno Depressivo

  en

  F03.080.400 Generalized Anxiety Disorder

  pt-br

  F03.080.400 Transtorno de Ansiedade Generalizado

Interventions

• Interventions:

  en

  There is no intervention. This is a prospective, quantitative observational study with a cohort design. The study will recruit 202 patients of both sexes who are using full-spectrum medical cannabis oil containing approximately 12% cannabidiol (CBD) and 0.3% tetrahydrocannabidiol (THC), previously prescribed by a physician in a real-world clinical setting. An assessment will be conducted of the association between genetic variants in the CYP2C9, CYP3A4, and COMT genes and clinical outcomes related to efficacy and adverse effects. Clinical data will be collected via questionnaires, and genetic data will be obtained from saliva samples, with analysis supported by artificial intelligence models

  pt-br

  Não há intervenção. Trata-se de um estudo observacional, prospectivo e quantitativo, apresentando delineamento de coorte. Nele, serão recrutados 202 pacientes, de ambos os sexos, em uso do óleo full spectrum de cannabis medicinal de aproximadamente 12% cannabidiol (CBD) e 0.3% tetrahydrocannabidiol (THC), prescrito previamente por um médico, em contexto clínico real. Será realizado uma avaliação da associação entre variantes genéticas nos genes CYP2C9, CYP3A4 e COMT com desfechos clínicos de eficácia e efeitos adversos. Os dados clínicos serão coletados por meio de questionários, e dados genéticos com amostras de saliva, sendo a análise apoiada em modelos de inteligência artificial

• Descriptors:

  en

  D26.528 Medical Cannabis

  pt-br

  D26.528 Cannabis Medicinal

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 07/01/2026 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  202	-	18 Y	0

• Inclusion criteria:

  en

  Adults aged 18 or older; of both sexes; residing in the state of Santa Catarina; with a medical diagnosis of anxiety disorder and/or depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5); regularly using full-spectrum medicinal cannabis oil prescribed by their attending physician; cognitively capable of understanding the study procedures and providing free and informed consent

  pt-br

  Adultos com 18 anos ou mais; de ambos os sexos; residentes no estado de Santa Catarina; com diagnóstico médico de transtorno de ansiedade e/ou transtorno depressivo conforme os critérios do Manual diagnóstico e estatístico de transtornos mentais, 5ª edição (DSM-5); em uso regular de óleo de cannabis medicinal full spectrum prescrito pelo médico assistente; cognitivamente aptos a compreender os procedimentos do estudo e fornecer consentimento livre e esclarecido

• Exclusion criteria:

  en

  Individuals with medical contraindications to the use of medicinal cannabis; unable to provide the necessary saliva sample; lacking the minimum clinical data required for analysis; or who refuse to participate in the research or sign the informed consent form

  pt-br

  Indivíduos com contraindicação médica ao uso de cannabis medicinal; incapazes de fornecer a amostra de saliva necessária; sem os dados clínicos mínimos exigidos para a análise; que recusem a participar da pesquisa ou assinar o termo de consentimento livre e esclarecido

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase

Outcomes

• Primary outcomes:

  en

  Change in anxiety and depressive symptoms measured by GAD-7 and PHQ-9 scores over time (baseline to follow-up up to 90 days)

  pt-br

  Mudança nos sintomas de ansiedade e depressão, medida pelos escores GAD-7 e PHQ-9 ao longo do tempo (linha de base até seguimento de até 90 dias)

• Secondary outcomes:

  en

  Occurrence of adverse events associated with medical cannabis use, including sedation, mood changes, cognitive impairment, gastrointestinal symptoms, and other reported effects

  pt-br

  Ocorrência de eventos adversos associados ao uso de cannabis medicinal, incluindo sedação, alterações de humor, comprometimento cognitivo, sintomas gastrointestinais e outros efeitos relatados

Contacts

• Public contact
  • Full name: Aderbal Silva Aguiar
  • • Address: R. Pedro João Pereira, 150 - Centro Cívico
    • City: Araranguá / Brazil
    • Zip code: 88905-120
  • Phone: +55-48-996473639
  • Email: aderbal.aguiar@ufsc.br
  • Affiliation: Universidade Federal de Santa Catarina
   
• Scientific contact
  • Full name: Aderbal Silva Aguiar
  • • Address: R. Pedro João Pereira, 150 - Centro Cívico
    • City: Araranguá / Brazil
    • Zip code: 88905-120
  • Phone: +55-48-996473639
  • Email: aderbal.aguiar@ufsc.br
  • Affiliation: Universidade Federal de Santa Catarina
   
• Site contact
  • Full name: Aderbal Silva Aguiar
  • • Address: R. Pedro João Pereira, 150 - Centro Cívico
    • City: Araranguá / Brazil
    • Zip code: 88905-120
  • Phone: +55-48-996473639
  • Email: aderbal.aguiar@ufsc.br
  • Affiliation: Universidade Federal de Santa Catarina
   

Additional links:

• Download in ICTRP format