Cannabidiol Oil as an Add-on for Treatment-Resistant Major Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter trial is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of full-spectrum cannabidiol oil as an adjunctive treatment for adults with treatment-resistant major depressive disorder. Participants will continue their stable antidepressant regimen while receiving either CBD oil or placebo for 12 weeks. Outcomes include depressive symptoms, anxiety, sleep quality, perceived stress, and adverse effects. The trial aims to determine if CBD can improve clinical outcomes beyond standard therapy in this population. It is conducted in Brazil at UNISUL and UNILA with 120 participants recruited across sites.

Why it matters

Who can join: the full rules

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

Where it's running

• Universidade do Sul de Santa Catarina - UNISUL
  Tubarão, Santa Catarina, Brazil Recruiting

Study contacts

• Study coordinator: Rafael Mariano Bitencourt, PhD
• Email: bitencourtrm@gmail.com
• Phone: +55 48 9 8833-6460

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.