Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558201
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Open Label Extension Study of NCT06221852
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open Label Extension Study of NCT06221852 of the Ketogenic Diet in Participants With First Episode Bipolar Disorder
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
None
Brief Summary:
This is a 12-week open-label extension study for participants completing study NCT06221852
Detailed Description:
In this 12-week single arm open label extension study of NCT06221852 the investigators aim to assess the longer term efficacy safety and tolerability of the ketogenic diet in participants completing the randomized study phase of NCT06221852 Investigators will assess longer term effects on energy metabolism insulin resistance and psychiatric symptoms
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