Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397605
Status:
WITHDRAWN
Last Update Posted:
2014-09-18
First Post:
2006-11-07
Brief Title:
Cannabinoids in Bipolar Affective Disorder
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Cannabinoids in Bipolar Affective Disorder A Controlled Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study was never started and no patients were ever enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Some people with bipolar disorder who use cannabis marijuana claim that it eases the symptoms of depression and mania There are many chemicals called cannabinoids found in cannabis but two particular ones appear to have medicinal therapeutic effects These two compounds are delta-9-tetrahydrocannabinol THC and cannabidiol CBD These cannabinoids appear to have mood anxiety and sedative effects as well as have antipsychotic and anticonvulsant properties This study will try to find out if these cannabinoids can be of benefit as an add-on treatment in bipolar disorder and what effects it has on thinking power and memory
Detailed Description:
This study will be a within-subject random order double-blind cross-over study with standard clinical and neuropsychological ratings Duration is 13 weeks per subject Clinical assessments including mood ratings will be performed weekly Instructions and practice on the use of the spray will be given under supervision during a 2-week run-in period before baseline Patients can control the dosage of cannabinoids according to their symptoms by administering up to a maximum of 48 pump-controlled sprays per day Patients will be asked to abstain from using cannabis other than the study drug during the study Patients will be treated for 4 weeks with either the sublingual THCCBD spray or placebo spray This will be followed by a 2-week washout period before another 4 weeks of treatment with whichever study medication was not initially used Neurocognitive testing will be performed 3 times during the study A mood diary will be completed daily by each patient at home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None