drugset / Trial / NCT04732169
Cannabidiol for Treatment Resistant Depression
RandomizedCrossoverTriple-blindTreatment
Summary
With this study, the investigators will address the following scientific aims: 1. Demonstrate the antidepressant effects of CBD in human adults with treatment refractory MDD as measured by standard rating scales. 2. Confirm CBD's safety profile in human adult patients with MDD.
Timeline
- Start
- 2021-07-01
- Primary completion
- 2021-07-09
- Completion
- 2021-07-09
Publications
- Background Greenberg PE, Fournier AA, Sisitsky T, Pike CT, Kessler RC. The economic burden of adults with major depressive disorder in the United States (2005 and 2010). J Clin Psychiatry. 2015 Feb;76(2):155-62. doi: 10.4088/JCP.14m09298.
- Background Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
- Background Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M; STAR*D Study Team. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med. 2006 Mar 23;354(12):1231-42. doi: 10.1056/NEJMoa052963.
- Background Linge R, Jimenez-Sanchez L, Campa L, Pilar-Cuellar F, Vidal R, Pazos A, Adell A, Diaz A. Cannabidiol induces rapid-acting antidepressant-like effects and enhances cortical 5-HT/glutamate neurotransmission: role of 5-HT1A receptors. Neuropharmacology. 2016 Apr;103:16-26. doi: 10.1016/j.neuropharm.2015.12.017. Epub 2015 Dec 19.
- Background Silote GP, Sartim A, Sales A, Eskelund A, Guimaraes FS, Wegener G, Joca S. Emerging evidence for the antidepressant effect of cannabidiol and the underlying molecular mechanisms. J Chem Neuroanat. 2019 Jul;98:104-116. doi: 10.1016/j.jchemneu.2019.04.006. Epub 2019 Apr 27.
- Background Gall Z, Farkas S, Albert A, Ferencz E, Vancea S, Urkon M, Kolcsar M. Effects of Chronic Cannabidiol Treatment in the Rat Chronic Unpredictable Mild Stress Model of Depression. Biomolecules. 2020 May 22;10(5):801. doi: 10.3390/biom10050801.
- Background Shbiro L, Hen-Shoval D, Hazut N, Rapps K, Dar S, Zalsman G, Mechoulam R, Weller A, Shoval G. Effects of cannabidiol in males and females in two different rat models of depression. Physiol Behav. 2019 Mar 15;201:59-63. doi: 10.1016/j.physbeh.2018.12.019. Epub 2018 Dec 17.
- Background Sales AJ, Fogaca MV, Sartim AG, Pereira VS, Wegener G, Guimaraes FS, Joca SRL. Cannabidiol Induces Rapid and Sustained Antidepressant-Like Effects Through Increased BDNF Signaling and Synaptogenesis in the Prefrontal Cortex. Mol Neurobiol. 2019 Feb;56(2):1070-1081. doi: 10.1007/s12035-018-1143-4. Epub 2018 Jun 4.
- Background Cuttler C, Spradlin A, McLaughlin RJ. A naturalistic examination of the perceived effects of cannabis on negative affect. J Affect Disord. 2018 Aug 1;235:198-205. doi: 10.1016/j.jad.2018.04.054. Epub 2018 Apr 6.
- Background McGuire P, Robson P, Cubala WJ, Vasile D, Morrison PD, Barron R, Taylor A, Wright S. Cannabidiol (CBD) as an Adjunctive Therapy in Schizophrenia: A Multicenter Randomized Controlled Trial. Am J Psychiatry. 2018 Mar 1;175(3):225-231. doi: 10.1176/appi.ajp.2017.17030325. Epub 2017 Dec 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cannabidiol | Other / unclassified | 500 mg | Oral |
Indications
No indication recorded.