Cannabidiol Oil for Treatment-Resistant Depression
Cannabidiol Oil for Treatment-Resistant Major Depression
Recruiting
Phase 1Phase 2Interventional Study
Major Depressive Disorder (MDD)Treatment-resistant Depression (TRD)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 69
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Universidade do Sul de Santa Catarina · Government
Who this trial is looking for
This trial is looking for adults aged 18 to 69 who have major depressive disorder and haven't improved with existing treatments. Participants will receive either cannabidiol oil or a placebo along with their current antidepressant for 12 weeks and will be assessed for their symptoms and wellbeing.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 to 69 years old
I have been diagnosed with major depressive disorder
I have persistent depressive symptoms despite ongoing treatment
I have been on stable antidepressant treatment for at least four weeks
I live in Brazil
I can understand the study procedures and follow the requirements
I can provide written informed consent
You may not be able to join if
I currently use cannabis-derived products or cannabinoid medications
I have been diagnosed with bipolar disorder or schizophrenia
I have a current substance use disorder, except nicotine or caffeine
I am pregnant or breastfeeding
I have severe medical conditions that might interfere with the study
I have a history of allergy to Cannabis sativa products or MCT oil
I have active suicidal thoughts that need immediate help
I have participated in another clinical trial in the last 30 days
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 dis…
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.
Trial Locations
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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 p…
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
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