Ignite Creation Date:
2024-05-06 @ 4:29 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05004896
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2021-08-06
Brief Title:
Ketamine for Treatment-Resistant Bipolar Disorder
Sponsor:
Joshua Rosenblat
Organization:
University Health Network Toronto
Study Overview
Official Title:
Repeated Ketamine Infusions for Treatment-Resistant Bipolar Disorder A Randomized Double-blind Midazolam-controlled Phase II Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KET-BD
Brief Summary:
Growing evidence has supported rapid and robust antidepressant effects with subanesthetic doses of intravenous IV ketamine for treatment resistant depression TRD However no completed or ongoing randomized control trials RCTs have evaluated the effects of repeated doses of IV ketamine for a homogenous sample of patients with treatment-resistant bipolar disorder TRBD The primary research goal is to determine the acute antidepressant efficacy safety and tolerability of four repeated sub-anesthetic doses of IV ketamine in moderate to severe TRBD Secondary aims include evaluating effects of IV ketamine on suicidal ideations quality of life function and duration of effects Herein a two-site University Health Network and Ontario Shores Centre for Mental Health Sciences phase II double-blinded midazolam-controlled two-week RCT evaluating the efficacy safety and tolerability of four flexibly-dosed adjunctive ketamine infusions 05-075mgkg infused over 40 minutes for acute treatment of moderate to severe TRBD type I II is proposed The primary outcome will be Montgomery-Åsberg Depression Rating Scale MADRS scores determining the between group difference in change from baseline to day 14 using analysis of covariance ANCOVA with 14-day MADRS as the outcome and baseline MADRS and stratification variables sex bipolar type as covariates Secondary outcomes include evaluating response and remission rates safety tolerability including treatment-emergent mania and effects on suicidality anxiety quality of life function and the duration of effects to day 28
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None