NCT07696871 Cannabidiol Oil for Treatment-Resistant Major Depression
| NCT ID | NCT07696871 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Universidade do Sul de Santa Catarina |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2026-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07696871 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 69 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07696871 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07696871 currently recruiting?
Yes, NCT07696871 is actively recruiting participants. Contact the research team at bitencourtrm@gmail.com for enrollment information.
Where is the NCT07696871 trial being conducted?
This trial is being conducted at Tubarão, Brazil.
Who is sponsoring the NCT07696871 clinical trial?
NCT07696871 is sponsored by Universidade do Sul de Santa Catarina. The trial plans to enroll 120 participants.