Status:
ENROLLING_BY_INVITATION
Open Label Extension Study of NCT06221852
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Baszucki Family Foundation
Conditions:
Bipolar I Disorder
Schizoaffective Disorder
Eligibility:
All Genders
18-45 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Participants who met original entry criteria in, and completed, the randomized 12-week study of NCT06221852.
Exclusion
- No longer meeting original entry criteria from the randomized 12-week study of NCT06221852.
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06558201
Start Date
August 28 2024
End Date
December 30 2027
Last Update
April 17 2025
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02487