NCT07696871RecruitingPhase 1/2
Cannabidiol Oil for Treatment-Resistant Major Depression
Effects of Full-Spectrum Cannabidiol Oil on Symptoms of Treatment-Resistant Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 23 Jun 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Universidade do Sul de Santa Catarina
- Diseases
- Depression
- NCT number
- NCT07696871
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 120
- From 1 Jun 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of cannabis-derived products or cannabinoid-based medications
- Participation in another clinical trial within the previous 30 days
Other illness
- 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
Other
- Pregnancy or breastfeeding
- Active suicidal ideation or significant suicide risk requiring immediate intervention
- Inability to comply with study procedures or follow-up assessments
Who the study is looking for
- 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
Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidade do Sul de Santa Catarina - UNISUL Coordinator of this site? Confirm its status | Tubarão | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.