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It was interrupted due to the coronavirus pandemic outbreak.
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| Name | Class |
|---|---|
| Federal University of Rio Grande do Sul | OTHER |
| University of Sao Paulo | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental | Cannabidiol 150-300mg per day for 12 weeks. |
|
| Placebo | Placebo Comparator | Cannabidiol comparator for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | Cannabidiol as active intervention. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores. |
| 08 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in clinical global impression. |
| Up to weeks 08 and 12 |
| Improvement in anxiety symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects |
| Up to weeks 08 and 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Márcia Kauer-Sant'Anna, MD, PhD | Laboratory of Molecular Psychiatry, Hospital de ClÃnicas de Porto Alegre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37920963 | Derived | Pinto JV, Crippa JAS, Cereser KM, Vianna-Sulzbach MF, Silveira Junior EM, Santana da Rosa G, Testa da Silva MG, Hizo GH, Simao Medeiros L, Santana de Oliveira CE, Bristot G, Campos AC, Guimaraes FS, Hallak JEC, Zuardi AW, Yatham LN, Kapczinski F, Kauer-Sant'Anna M. Cannabidiol as an Adjunctive Treatment for Acute Bipolar Depression: A Pilot Study: Le cannabidiol comme traitement d'appoint de la depression bipolaire aigue : une etude pilote. Can J Psychiatry. 2024 Apr;69(4):242-251. doi: 10.1177/07067437231209650. Epub 2023 Nov 3. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Double-blind, randomized and placebo controlled study
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| Drug |
Placebo intervention. |
|
|
| Up to weeks 08 and 12 |
| Improvement in functioning. |
| Up to weeks 08 and 12 |
| Improvement in biological rhythms. |
| Up to weeks 08 and 12 |
| Change in BDNF levels in the blood. | Change in brain-derived neurotrophic factor (BDNF) levels in the blood. | Up to weeks 08 and 12 |
| Change in inflammatory levels in the blood. | Change in inflammatory levels in the blood (cytokines, chemokines and C-reactive protein). | Up to weeks 08 and 12 |
| Change in endocannabinoid levels in the blood. | Change in endocannabinoid levels in the blood (anandamide and 2-arachidonoylglycerol). | Up to weeks 08 and 12 |
| Remission of manic symptoms. |
| Up to weeks 08 and 12 |
| Change in depressive symptoms |
| Up to weeks 08 and 12 |
| Change in psychotic symptoms |
| Up to weeks 08 and 12 |
| Change in depressive symptoms according to MADRS |
| Up to week 12 |
| Change in depressive symptoms according to PHQ-9 |
| Up to weeks 08 and 12 |
| Change in oxidative stress markers levels in the blood. | Change in oxidative stress markers levels in the blood. | Up to weeks 08 and 12 |