Cannabidiol
Cannabidiol as active intervention.
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Depressive symptoms are associated with significant psychosocial impairment. However, current treatments of bipolar depression are only partially effective. Cannabidiol is a natural component of cannabis without psychotomimetic or addictive properties. Cannabidiol has been shown to produce therapeutic effects including anticonvulsive, anxiolytic, antipsychotic and neuroprotective effects. The investigators hypothesize that treatment with cannabidiol will result in improvement of depressive and anxiety symptoms, as well as, improvement in functioning and inflammatory biomarkers. During the clinical trial, subjects will receive study medication (cannabidiol 150-300mg/day) or placebo for a period of 12 weeks.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2021-07-02
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Cannabidiol as active intervention.
Placebo intervention.
Eligibility
primary outcomes
Time frame: 08 weeks
* Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores. * Scale range: from 0 to 60. * Higher values represent more severe symptoms of depression.
secondary outcomes
Time frame: Up to weeks 08 and 12
* Change from baseline in Clinical Global Impression(CGI-BP) scores. * Scale range: from 1 to 7. * Higher values represent more severe symptoms of bipolar disorder.
Time frame: Up to weeks 08 and 12
* Change from baseline in Hamilton Anxiety Rating Scale (HAMA). * Scale range: from 0 to 56. * Higher values represent more severe symptoms of anxiety.
Time frame: Up to weeks 08 and 12
* Change from baseline Functioning Assessment Short Test (FAST) scores. * Scale range: from 0 to 72. * Higher values represent more severe functional impairment.
Time frame: Up to weeks 08 and 12
* Improvement in biological rhythms according to Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN). * Scale range: from 0 to 88. * Higher values represent more severe symptoms of biological rhythms.
Time frame: Up to weeks 08 and 12
Change in brain-derived neurotrophic factor (BDNF) levels in the blood.
Time frame: Up to weeks 08 and 12
Change in inflammatory levels in the blood (cytokines, chemokines and C-reactive protein).
Time frame: Up to weeks 08 and 12
Change in endocannabinoid levels in the blood (anandamide and 2-arachidonoylglycerol).
Time frame: Up to weeks 08 and 12
* Change from baseline in the Young Mania Rating Scale (YMRS) score. * Scale range: from 0 to 58. * Higher values represent more severe symptoms of mania.
Time frame: Up to weeks 08 and 12
* Change from baseline in Hamilton Depression Rating Scale (HAMD) score. * Scale range: from 0 to 52. * Higher values represent more severe symptoms of depression.
Time frame: Up to weeks 08 and 12
* Change from baseline in Brief Psychiatric Rating Scale (BPRS) score. * Scale range: from 0 to 108. * Higher values represent more severe symptoms of psychosis.
Time frame: Up to week 12
* Higher values represent more severe symptoms of depression. * Scale range: from 0 to 60.
Time frame: Up to weeks 08 and 12
* Change from baseline in Patient Health Questionnaire (PHQ-9) score. * Scale range: from 0 to 27.
Time frame: Up to weeks 08 and 12
Change in oxidative stress markers levels in the blood.
other outcomes
Time frame: Up to weeks 08 and 12
* Evaluation of side effects according Udvalg for Kliniske Undersogelser (UKU) side effects rating scale. * Scale range: from 0 to 144. * Higher values represent more severe side effects associated to medications.
Publications
No exact PMID-linked public article is currently readable locally.