Cannabidiol as an Adjunctive Treatment for Bipolar Depression

Summary

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.

Timeline

Start

2017-11-01

Primary completion

2020-02-24

Completion

2020-03-24

Outcome

Missed primary endpoint

Stopped: “It was interrupted due to the coronavirus pandemic outbreak.”

paper MADRS scores significantly decreased from baseline to the endpoint (placebo, -14.56; cannabidiol, -15.38), but there was no significant difference between the groups. PMID 37920963 ↗

paper Despite the negative finding on the primary outcome PMID 37920963 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cannabidiol	Other / unclassified	150 mg	—
Subject	Cannabidiol	Other / unclassified	300 mg	—

Indications