Major Depressive Disorder (MDD)Phase 1/2ANANDANCT07696871
Cannabidiol Oil for Treatment-Resistant Major Depression
A Phase 1/2 study testing Full-spectrum CBD oil 100 mg/mL in people with Major Depressive Disorder (MDD) and Treatment-resistant Depression (TRD), run by Universidade do Sul de Santa Catarina at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Treatment-resistant Depression (TRD)
- What is being tested?
- Full-spectrum CBD oil 100 mg/mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade do Sul de Santa Catarina - UNISUL
Tubarão, Santa Catarina, 88704900
Rafael Mariano Bitencourt, PhD, +55 48 9 8833-6460, bitencourtrm@gmail.com
About this study
Official title: Effects of Full-Spectrum Cannabidiol Oil on Symptoms of Treatment-Resistant Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical 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.
Read more
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.
Read the detailed description
Major depressive disorder (MDD) is a highly prevalent psychiatric condition and one of the leading causes of disability worldwide. Despite the availability of several antidepressant treatments, approximately one-third of patients do not achieve adequate symptom remission after multiple treatment attempts, characterizing treatment-resistant depression. This condition is associated with substantial functional impairment, reduced quality of life, increased healthcare utilization, and elevated suicide risk.
The endocannabinoid system has emerged as a promising target for the treatment of mood disorders because of its involvement in emotional regulation, stress response, neuroplasticity, neuroinflammation, and neurotransmitter modulation. Cannabidiol (CBD), a non-intoxicating phytocannabinoid derived from Cannabis sativa, has demonstrated anxiolytic, anti-inflammatory, neuroprotective, and antidepressant-like effects in preclinical studies, while preliminary clinical evidence suggests potential benefits in psychiatric disorders.
The ANANDA trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy, safety, and tolerability of full-spectrum cannabidiol oil as adjunctive therapy in adults with treatment-resistant major depressive disorder.
The study will be conducted at the University of Southern Santa Catarina (UNISUL) and the Federal University for Latin American Integration (UNILA). A total of 120 participants diagnosed with treatment-resistant major depressive disorder will be randomized in a 1:1 ratio to receive either full-spectrum cannabidiol oil or placebo for 12 weeks while maintaining stable antidepressant treatment.
Randomization will be performed using a computer-generated allocation sequence. Participants, investigators, healthcare providers, outcome assessors, and members of the research team responsible for participant follow-up and data analysis will remain blinded to treatment allocation throughout the study period. The placebo formulation will be matched to the active intervention in appearance, color, packaging, and administration conditions to maintain blinding.
Clinical evaluations will be performed at baseline, Week 4, and Week 12 using validated instruments for depressive symptoms, anxiety, sleep quality, perceived stress, adverse effects, and quality of life. Biological samples will be collected at baseline and after 12 weeks of treatment to assess inflammatory and neuroendocrine biomarkers potentially associated with treatment response.
The primary outcome is the change in depressive symptom severity measured by the Montgomery-Åsberg Depression Rating Scale after 12 weeks of treatment. Secondary outcomes include changes in anxiety symptoms, sleep quality, perceived stress, biological markers, safety, and treatment tolerability.
The results of this study may contribute to a better understanding of the therapeutic potential of cannabidiol in treatment-resistant depression and may provide evidence to support future clinical applications of cannabinoid-based interventions in psychiatry.
- Being tested
- Full-spectrum CBD oil 100 mg/mL, Placebo oil (MCT oil)
- Keywords
- Cannabidiol, Cannabinoids, Major Depressive Disorder, Treatment-Resistant Depression, Mood Disorders
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-spectrum CBD oil 100 mg/mLDrug
Full-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)Drug
Placebo 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.
| Study group | Role | What they receive |
|---|---|---|
| CBD Full Spectrum 100 mg/mL | Experimental | Participants assigned to this arm will receive full-spectrum cannabidiol (CBD) oil containing 100 mg/mL of CBD administered sublingually for 12 weeks under double-blind conditions. The formulation contains cannabidiol and naturally occurring phytocannabinoids and terpenes derived from Cannabis sativa. Clinical assessments will be conducted at baseline, Week 4, and Week 12 to evaluate efficacy, safety, tolerability, and treatment adherence. Receives: Drug: Full-spectrum CBD oil 100 mg/mL |
| Placebo (MCT oil) | Placebo comparator | Participants assigned to this arm will receive a placebo formulation consisting of medium-chain triglyceride (MCT) oil administered sublingually for 12 weeks under double-blind conditions. The placebo will be identical in appearance, color, viscosity, taste, and packaging to the active full-spectrum CBD oil to ensure maintenance of treatment blinding. Clinical assessments will be conducted at baseline, Week 4, and Week 12 to evaluate study outcomes, safety, tolerability, and adherence. Receives: Drug: Placebo oil (MCT oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, and Week 12
Secondary outcomes (6)
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.
Measured: Baseline, Week 4, and Week 12
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.
Measured: Baseline, Week 4, and Week 12
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.
Measured: Baseline, Week 4, and Week 12
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.
Measured: Week 4 and Week 12
Change in Inflammatory Biomarkers
Inflammatory biomarkers will be assessed in serum samples collected at baseline and after 12 weeks of treatment. Biomarkers will include tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1 beta), interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and C-reactive protein (CRP). Concentrations will be measured using enzyme-linked immunosorbent assay (ELISA) and expressed in picograms per milliliter (pg/mL), except for CRP when applicable. The secondary endpoint is the change in inflammatory biomarker concentrations from baseline to Week 12.
Measured: Baseline and Week 12
Change in Neuroendocrine Biomarkers
Neuroendocrine biomarkers will be assessed in serum samples collected at baseline and after 12 weeks of treatment. Biomarkers will include brain-derived neurotrophic factor (BDNF) and cortisol, which are associated with neuroplasticity, stress regulation, and the pathophysiology of major depressive disorder. Concentrations will be measured using validated laboratory methods and expressed according to standard laboratory units. The secondary endpoint is the change in neuroendocrine biomarker concentrations from baseline to Week 12.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial with a parallel-group assignment. Participants will be randomly allocated in a 1:1 ratio to either the intervention group receiving full-spectrum cannabidiol (CBD) oil or the placebo group receiving a matched placebo formulation with similar organoleptic characteristics and administration conditions. Participants will remain in their assigned group throughout the 12-week intervention period, with no crossover between treatments. Clinical assessments will be conducted at baseline, Week 4, and Week 12, with additional remote follow-up visits performed throughout the study to monitor treatment adherence, tolerability, adverse events, and dose adjustments. Blood samples will be collected at baseline and after 12 weeks to evaluate inflammatory and neuroendocrine biomarkers associated with treatment response.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Sul de Santa Catarina
- Sponsor type
- Other government
- Collaborators
- Federal University of Latin American Integration, Associação Cannabis Sem Fronteiras - ACSF
- Responsible party
- Principal investigator, Rafael Mariano de Bitencourt, Universidade do Sul de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696871
- Sponsor's protocol ID
- CEP-UNISUL-8469525
- Other IDs
- RBR-6n6wzsx, U1111-1337-1000, CAAE 88825025.3.0000.0261
- Acronym
- ANANDA
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Full-Spectrum Cannabidiol Oil on Symptoms of Treatment-Resistant Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT07696871
- Acronym / sponsor ID
- ANANDA / CEP-UNISUL-8469525
- Keywords
- Cannabidiol, Cannabinoids, Major Depressive Disorder, Treatment-Resistant Depression, Mood Disorders
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidade do Sul de Santa CatarinaOther government
- Collaborators
- Federal University of Latin American Integration, Associação Cannabis Sem Fronteiras - ACSF
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Major depressive disorder (MDD) is a highly prevalent psychiatric condition and one of the leading causes of disability worldwide. Despite the availability of several antidepressant treatments, approximately one-third of patients do not achieve adequate symptom remission after multiple treatment attempts, characterizing treatment-resistant depression. This condition is associated with substantial functional impairment, reduced quality of life, increased healthcare utilization, and elevated suicide risk.
The endocannabinoid system has emerged as a promising target for the treatment of mood disorders because of its involvement in emotional regulation, stress response, neuroplasticity, neuroinflammation, and neurotransmitter modulation. Cannabidiol (CBD), a non-intoxicating phytocannabinoid derived from Cannabis sativa, has demonstrated anxiolytic, anti-inflammatory, neuroprotective, and antidepressant-like effects in preclinical studies, while preliminary clinical evidence suggests potential benefits in psychiatric disorders.
The ANANDA trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy, safety, and tolerability of full-spectrum cannabidiol oil as adjunctive therapy in adults with treatment-resistant major depressive disorder.
The study will be conducted at the University of Southern Santa Catarina (UNISUL) and the Federal University for Latin American Integration (UNILA). A total of 120 participants diagnosed with treatment-resistant major depressive disorder will be randomized in a 1:1 ratio to receive either full-spectrum cannabidiol oil or placebo for 12 weeks while maintaining stable antidepressant treatment.
Randomization will be performed using a computer-generated allocation sequence. Participants, investigators, healthcare providers, outcome assessors, and members of the research team responsible for participant follow-up and data analysis will remain blinded to treatment allocation throughout the study period. The placebo formulation will be matched to the active intervention in appearance, color, packaging, and administration conditions to maintain blinding.
Clinical evaluations will be performed at baseline, Week 4, and Week 12 using validated instruments for depressive symptoms, anxiety, sleep quality, perceived stress, adverse effects, and quality of life. Biological samples will be collected at baseline and after 12 weeks of treatment to assess inflammatory and neuroendocrine biomarkers potentially associated with treatment response.
The primary outcome is the change in depressive symptom severity measured by the Montgomery-Åsberg Depression Rating Scale after 12 weeks of treatment. Secondary outcomes include changes in anxiety symptoms, sleep quality, perceived stress, biological markers, safety, and treatment tolerability.
The results of this study may contribute to a better understanding of the therapeutic potential of cannabidiol in treatment-resistant depression and may provide evidence to support future clinical applications of cannabinoid-based interventions in psychiatry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study is designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial with a parallel-group assignment. Participants will be randomly allocated in a 1:1 ratio to either the intervention group receiving full-spectrum cannabidiol (CBD) oil or the placebo group receiving a matched placebo formulation with similar organoleptic characteristics and administration conditions. Participants will remain in their assigned group throughout the 12-week intervention period, with no crossover between treatments. Clinical assessments will be conducted at baseline, Week 4, and Week 12, with additional remote follow-up visits performed throughout the study to monitor treatment adherence, tolerability, adverse events, and dose adjustments. Blood samples will be collected at baseline and after 12 weeks to evaluate inflammatory and neuroendocrine biomarkers associated with treatment response.
| Arm | Type | Receives |
|---|---|---|
| CBD Full Spectrum 100 mg/mL | Experimental | Drug: Full-spectrum CBD oil 100 mg/mLParticipants assigned to this arm will receive full-spectrum cannabidiol (CBD) oil containing 100 mg/mL of CBD administered sublingually for 12 weeks under double-blind conditions. The formulation contains cannabidiol and naturally occurring phytocannabinoids and terpenes derived from Cannabis sativa. Clinical assessments will be conducted at baseline, Week 4, and Week 12 to evaluate efficacy, safety, tolerability, and treatment adherence. |
| Placebo (MCT oil) | Placebo comparator | Drug: Placebo oil (MCT oil)Participants assigned to this arm will receive a placebo formulation consisting of medium-chain triglyceride (MCT) oil administered sublingually for 12 weeks under double-blind conditions. The placebo will be identical in appearance, color, viscosity, taste, and packaging to the active full-spectrum CBD oil to ensure maintenance of treatment blinding. Clinical assessments will be conducted at baseline, Week 4, and Week 12 to evaluate study outcomes, safety, tolerability, and adherence. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-spectrum CBD oil 100 mg/mLFull-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. | Drug | CBD Full Spectrum 100 mg/mL |
| Placebo oil (MCT oil)Placebo 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. | Drug | Placebo (MCT oil) |
Primary outcome
Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HAM-17)
Time frame: Baseline, Week 4, and Week 12
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.
6 secondary outcomes
Change in Anxiety Symptoms Assessed by the Generalized Anxiety Disorder Scale (GAD-7)
Time frame: Baseline, Week 4, and Week 12
Change in Insomnia Severity Assessed by the Insomnia Severity Index (ISI)
Time frame: Baseline, Week 4, and Week 12
Change in Health-Related Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)
Time frame: Baseline, Week 4, and Week 12
Frequency and Severity of Adverse Effects Assessed by the UKU Side Effect Rating Scale
Time frame: Week 4 and Week 12
Change in Inflammatory Biomarkers
Time frame: Baseline and Week 12
Change in Neuroendocrine Biomarkers
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Full-spectrum CBD oil 100 mg/mL in people with Major Depressive Disorder (MDD) and Treatment-resistant Depression (TRD), run by Universidade do Sul de Santa Catarina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael Mariano Bitencourt, PhD (+55 48 9 8833-6460, bitencourtrm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HAM-17) (time frame: Baseline, Week 4, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.