Tests cannabidiol oil alongside antidepressants for treatment-resistant depression
Tests cannabidiol oil or placebo added to usual medicine in adults with hard-to-treat depression.
Plain-language title generated from the registry record
Registry title: Cannabidiol Oil for Treatment-Resistant Major Depression
Key facts
- Where
- Tubarão, BrazilSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 69 years old?
Source: NCT07696871, who can take part
Where in Brazil
- Universidade do Sul de Santa Catarina - UNISULTubarão, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universidade do Sul de Santa Catarina
- Trial code
- NCT07696871
- Record updated
- 10 July 2026
- Original description
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.Read full original descriptionShow less
Effects of Full-Spectrum Cannabidiol Oil on Symptoms of Treatment-Resistant Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial
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.
Inclusion: 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: Current use of cannabis-derived products or cannabinoid-based medications; Participation in another clinical trial within the previous 30 days; Diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders; Current substance use disorder, except nicotine or caffeine; Severe or unstable medical conditions that may interfere with study participation; History of hypersensitivity or allergy to Cannabis sativa products or MCT oil; Pregnancy or breastfeeding; Active suicidal ideation or significant suicide risk requiring immediate intervention; Inability to comply with study procedures or follow-up assessments.