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Cannabidiol Oil for Treatment-Resistant Major Depression

RecruitingPhase 1, Phase 2Ages 18 Years - 69 YearsAllUniversidade do Sul de Santa Catarina
NCT07696871 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Major depressive disorder is one of the leading causes of disability worldwide, and a substantial proportion of patients do not achieve adequate improvement with conventional antidepressant treatments. Cannabidiol (CBD), a non-intoxicating cannabinoid derived from Cannabis sativa, has shown potential anxiolytic, anti-inflammatory, and neurobiological effects that may be relevant for depressive disorders. The ANANDA trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety, and tolerability of full-spectrum cannabidiol oil as an adjunctive treatment in adults with treatment-resistant major depressive disorder. A total of 120 participants will be randomly assigned to receive either full-spectrum cannabidiol oil or placebo for 12 weeks while maintaining stable antidepressant treatment. Clinical assessments of depressive s

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 to 69 years * Diagnosis of Major Depressive Disorder (MDD) * Persistent depressive symptoms despite ongoing antidepressant treatment * Stable antidepressant treatment for at least four weeks before enrollment * Residence in Brazil * Ability to understand study procedures and comply with study requirements * Provision of written informed consent Exclusion Criteria: * Current use of cannabis-derived products or cannabinoid-based medications * Diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders * Current substance use disorder, except nicotine or caffeine * Pregnancy or breastfeeding * Severe or unstable medical conditions that may interfere with study participation * History of hypersensitivity or allergy to Cannabis sativa products or MCT oil * Active suicidal ideation or significant suicide risk requiring immediate intervention * Participation in another clinical trial within the previous 30 days * Inability to comply with study procedures or follow-up assessments
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What it tests

  • Full-spectrum CBD oil 100 mg/mL
  • Placebo oil (MCT oil)
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Where

1 site
Universidade do Sul de Santa Catarina - UNISUL
Tubarão, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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