Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559826
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Ketamine-Assisted Psychotherapy KAP Compared to Ketamine Alone for the Treatment of Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized-Controlled Trial of Ketamine-Assisted Psychotherapy KAP Compared to Ketamine Alone for the Treatment of Depression
Status:
RECRUITING
Status Verified Date:
2024-09
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:
KAP
Brief Summary:
The proposed study is a single-site randomized controlled clinical trial RCT comparing ketamine-assisted psychotherapy KAP to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy KET Eligible study participants will be adults with major depressive disorder MDD Adults with MDD will be randomized to KAP or KET in a 11 allocation Each treatment group will receive KAP or KET over a period of four weeks Measurement of depression severity wellness neurocognitive functioning and other parameters will occur at baseline prior to treatment immediately following the end of the acute treatment period and over an 8-week two month treatment follow-up period
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