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Sponsor: Universidade do Sul de Santa Catarina
Conditions: Major Depressive Disorder (MDD), Treatment-resistant Depression (TRD)
Interventions: Full-spectrum CBD oil 100 mg/mL, Placebo oil (MCT oil)
Countries: Brazil
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 symptoms, anxiety, sleep quality, perceived stress, and adverse effects will be performed at baseline, Week 4, and Week 12. Blood samples will be collected at baseline and after 12 weeks to investigate inflammatory and neuroendocrine biomarkers. The primary objective is to evaluate changes in depressive symptoms after 12 weeks of treatment. Secondary objectives include the assessment of anxiety, sleep quality, perceived stress, biological markers, safety, and tolerability. The findings of this study may contribute to the development of new therapeutic approaches for treatment-resistant depression and provide additional evidence regarding the clinical use of cannabidiol in psychiatric disorders.
Sex: ALL
Age: 18 Years to 69 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Tubarão, Santa Catarina, Brazil