Cannabidiol Oil for Treatment-Resistant Major Depression
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-69
SponsorUniversidade do Sul de Santa Catarina
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Full-spectrum CBD oil 100 mg/mL
DrugFull-spectrum Cannabis sativa extract containing cannabidiol (CBD) 100 mg/mL and tetrahydrocannabinol (THC) 3.33 mg/mL, administered sublingually for 12 weeks according to a structured dose titration schedule. Treatment will begin with low doses and may be gradually adjusted based on clinical response and tolerability, respecting predefined safety limits established in the study protocol.
Placebo oil (MCT oil)
DrugPlacebo comparator consisting of medium-chain triglyceride (MCT) oil administered sublingually for 12 weeks according to the same dose titration schedule used in the experimental group. The placebo formulation is matched to the active intervention in appearance, color, viscosity, packaging, and administration conditions to maintain blinding throughout the study. Treatment adherence, tolerability, and adverse events will be monitored throughout the intervention period.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: CBD Full Spectrum 100 mg/mLExperimental treatment 1 intervention
Group B: Placebo (MCT oil)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HAM-17)
Depressive symptoms will be assessed using the 17-item Hamilton Depression Rating Scale (HAM-17), a clinician-administered instrument that evaluates depressive symptom severity. HAM-17 assessments will be performed at baseline, Week 4, and Week 12. The primary endpoint is the change in HAM-17 total score from baseline to Week 12. Changes from baseline to Week 4 will be evaluated as an intermediate assessment.
Time frame
Baseline, Week 4, and Week 12Secondary outcomes
1
Change in Anxiety Symptoms Assessed by the Generalized Anxiety Disorder Scale (GAD-7)
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder Scale (GAD-7), a 7-item self-report instrument that evaluates the frequency of anxiety-related symptoms. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity. GAD-7 assessments will be performed at baseline, Week 4, and Week 12. The secondary endpoint is the change in GAD-7 total score from baseline to Week 12, with Week 4 evaluated as an intermediate assessment.
Time frame
Baseline, Week 4, and Week 122
Change in Insomnia Severity Assessed by the Insomnia Severity Index (ISI)
Sleep disturbances will be assessed using the Insomnia Severity Index (ISI), a 7-item self-report instrument that evaluates the severity of insomnia symptoms, sleep dissatisfaction, interference with daily functioning, and distress associated with sleep difficulties during the previous two weeks. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 28, with higher scores indicating greater insomnia severity. ISI assessments will be performed at baseline, Week 4, and Week 12. The secondary endpoint is the change in ISI total score from baseline to Week 12, with Week 4 evaluated as an intermediate assessment.
Time frame
Baseline, Week 4, and Week 123
Change in Health-Related Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)
Health-related quality of life will be assessed using the 36-item Short Form Health Survey (SF-36), a validated self-report instrument composed of eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life. Assessments will be performed at baseline, Week 4, and Week 12. The secondary endpoint is the change in SF-36 domain scores from baseline to Week 12, with Week 4 evaluated as an intermediate assessment.
Time frame
Baseline, Week 4, and Week 124
Frequency and Severity of Adverse Effects Assessed by the UKU Side Effect Rating Scale
Treatment tolerability and adverse effects will be assessed using the UKU Side Effect Rating Scale, a standardized instrument developed to systematically evaluate adverse effects associated with psychopharmacological treatments. The UKU assesses psychiatric, neurological, autonomic, and other general side effects. Each item is scored on a scale ranging from 0 (absent) to 3 (severe), with higher scores indicating a greater burden of adverse effects. Assessments will be performed at Week 4 and Week 12 to evaluate the safety and tolerability of the intervention.
Time frame
Week 4 and Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade do Sul de Santa Catarina
Lead sponsor
Federal University of Latin American Integration
Collaborator
Associação Cannabis Sem Fronteiras - ACSF
Collaborator
Source ClinicalTrials.gov