Effects of Full-Spectrum Cannabidiol Oil on Symptoms of Treatment-Resistant Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HAM-17)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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. The placebo formulation will be matched to the active intervention in appearance, color, packaging, and administration conditions to maintain blinding. Treatment allocation codes will be restricted to designated personnel not directly involved in participant assessments, clinical follow-up, or outcome evaluations and will only be accessed in cases of medical necessity or after completion of the study.
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HAM-17)
时间窗: 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.
次要结局
- Change in Anxiety Symptoms Assessed by the Generalized Anxiety Disorder Scale (GAD-7)(Baseline, Week 4, and Week 12)
- Change in Insomnia Severity Assessed by the Insomnia Severity Index (ISI)(Baseline, Week 4, and Week 12)
- Change in Health-Related Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)(Baseline, Week 4, and Week 12)
- Frequency and Severity of Adverse Effects Assessed by the UKU Side Effect Rating Scale(Week 4 and Week 12)
- Change in Inflammatory Biomarkers(Baseline and Week 12)
- Change in Neuroendocrine Biomarkers(Baseline and Week 12)
研究者
Rafael Mariano de Bitencourt
Principal Investigator
Universidade do Sul de Santa Catarina