Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05339074
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2022-04-13
Brief Title:
Maintenance Ketamine Infusions for Treatment-Resistant Bipolar Depression
Sponsor:
Joshua Rosenblat
Organization:
University Health Network Toronto
Study Overview
Official Title:
Maintenance Ketamine Infusions for Treatment-Resistant Bipolar Depression An Open-Label Extension 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-Sustain
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 RCTs have evaluated the effects of repeated doses of IV ketamine for a homogenous sample of patients with treatment-resistant bipolar disorder depression TRBD The primary research goal is to determine the acute antidepressant efficacy safety and tolerability of repeated sub-anesthetic maintenance doses of IV ketamine in over a period of twelve weeks Open-label ketamine infusions will be provided on a flexible schedule every 2-4 weeks with flexible dosing 05-10mgkg over 40 minutes titrated to optimize benefits while minimizing the dosage and frequency over a 12-week extension period All patients participating in this open-label study will have completed an acute course of infusions in a parent two-site phase II double-blinded midazolam-controlled RCT trial In addition to this acute course of four infusions a maximum of six infusions will be provided over the 12-week period 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 single-arm open label 12-week extension trial evaluating the effects of flexibly-dosed adjunctive ketamine infusions for TRBD to maintain antidepressant effects in participants who achieved an antidepressant response MADRS decrease by 50 or remission MADRS 12 following an acute course of four ketamine infusions is proposed The primary outcome will be Montgomery-Åsberg Depression Rating Scale MADRS scores determining by a linear mixed model from baseline to week 12 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
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