Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508710
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Early Effects of Ketamine vs Placebo With Venlafaxine in Severe Depression Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Efficacy of Ketamine Compared With Placebo as Adjunctive Therapy With Venlafaxine in Severely Unipolar Depressed Inpatients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOODBOOSTER
Brief Summary:
Unipolar major depressive disorder is the leading cause of disability worldwide The most commonly used treatments for major depressive episodes MDE are antidepressant medications However they have limited efficacy and their onset of action is long ranging between 2 to 6 weeks During this period hospitalization can become necessary especially for severe MDE It is crucial to improve the early effectiveness of treatments for these patients in order to alleviate their suffering limit complications suicidal risk and reduce hospitalization durations approximately 1000 euros per day The efficacy of intravenous ketamine has been demonstrated in pharmaco-resistant depression but remains to be proven in non-pharmaco-resistant severe MDE Additionally PET imaging using 11CUCB-J which allows the in vivo study of synaptic density in the human brain has shown significant decreases in synaptic density in unipolar patients with severe MDE Furthermore a single ketamine infusion was found to enhance synaptogenesis
Detailed Description:
None
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