Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-06-02 @ 7:56 PM
Study NCT ID:
NCT03310593
Status:
TERMINATED
Last Update Posted:
2021-07-02
First Post:
2017-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabidiol as an Adjunctive Treatment for Bipolar Depression
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Study Overview
Official Title:
A Double-blind, Randomized, Placebo-controlled Clinical Trial of Adjunctive Cannabidiol for Bipolar Depression
Status:
TERMINATED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It was interrupted due to the coronavirus pandemic outbreak.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBDBD
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: