Major depressive disorder Recurrent depressive disorder
Conditions
Interventions
This is a randomized controlled clinical trial with two parallel arms and a double blind design conducted in adult participants diagnosed with treatment resistant Major Depressive Disorder. The study
Sponsors
Sociedade De Educação Superior e Cultura Brasil S.A.
Associação Cannabis Sem Fronteiras
Eligibility
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: Adult participants aged between eighteen and sixty nine years; residents of municipalities in the Greater Florianopolis region; previous diagnosis of Major Depressive Disorder confirmed according to the Diagnostic and Statistical Manual of Mental Disorders fifth edition text revision of the American Psychiatric Association; presence of a major depressive episode characterized by depressed mood and or loss of interest or pleasure for at least two weeks associated with additional symptoms compatible with the clinical diagnosis; current use of antidepressant medication for at least sixty days without satisfactory clinical response characterizing treatment resistant depression; voluntary agreement to participate in the study through signing the informed consent form
Exclusion criteria
Exclusion criteria: Use of cannabinoid substances natural or synthetic within thirty days prior to the beginning of the study; history of intolerance or adverse reaction to components of the Cannabis plant including confusion paranoia pruritus excessive somnolence vomiting diarrhea or seizures; women who are pregnant planning pregnancy or breastfeeding; presence of severe medical illness or clinical condition that may interfere with the evaluation of study outcomes; presence of decompensated psychiatric comorbidity including psychotic disorders severe personality disorders or active suicidal ideation; moderate or severe cognitive impairment that prevents adequate understanding of study assessment instrumentstivo moderado ou grave que impeça a adequada compreensão dos instrumentos de avaliação do estudo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the reduction in the severity of depressive symptoms in participants with treatment resistant Major Depressive Disorder undergoing intervention with full spectrum cannabidiol oil for twelve weeks verified using the Montgomery Asberg Depression Rating Scale applied at baseline and at week twelve of follow up with the outcome being determined by the variation in the total score of the scale between the two assessment time points | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate changes in clinical and biological parameters associated with Major Depressive Disorder in participants undergoing intervention with full spectrum cannabidiol oil for twelve weeks verified using the Pittsburgh Sleep Quality Index for sleep quality the Hamilton Anxiety Rating Scale for anxiety levels and the Perceived Stress Scale for perceived stress applied at baseline and at week twelve of follow up with the outcome being determined by the variation in the scores of these instruments between the assessment time points in addition to the analysis of inflammatory and neuroendocrine biomarkers obtained through the collection of blood and saliva samples performed during the study as well as the evaluation of safety and tolerability of cannabidiol oil through the recording and monitoring of adverse events throughout the twelve week follow up period | — |
Countries
BR
Contacts
Public ContactRafael Bitencourt
Universidade do Sul de Santa Catarina (UNISUL)
Outcome results
None listed