Recruiting

Cannabidiol Oil for Treatment-Resistant Major Depression

ClinicalTrials.gov IDNCT07696871

PhasePHASE1, PHASE2

Enrollment120

SponsorUniversidade do Sul de Santa Catarina

Age18 Years

SexALL

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Conditions studied

Major Depressive Disorder (MDD), Treatment-resistant Depression (TRD)

About this study

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.

Interventions

Drug: Full-spectrum CBD oil 100 mg/mL — Full-spectrum Cannabis sativa extract containing cannabidiol (CBD) 100 mg/mL and tetrahydrocannabinol (THC) 3.33 mg/mL, administered sublingually for 12 weeks according to a structured dose titration schedule. Treatment will begin with low doses and may be gradually adjusted based on clinical response and tolerability, respecting predefined safety limits established in the study protocol.
Drug: Placebo oil (MCT oil) — Placebo comparator consisting of medium-chain triglyceride (MCT) oil administered sublingually for 12 weeks according to the same dose titration schedule used in the experimental group. The placebo formulation is matched to the active intervention in appearance, color, viscosity, packaging, and administration conditions to maintain blinding throughout the study. Treatment adherence, tolerability, and adverse events will be monitored throughout the intervention period.

Primary outcomes

Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HAM-17) (Baseline, Week 4, and Week 12)

Eligibility information

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

Study locations

Universidade do Sul de Santa Catarina - UNISUL, Tubarão, Santa Catarina 88704900 Brazil

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.