Open Label Extension Study of NCT06221852
NCT06558201 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-04-17
Summary
This is a 12-week open-label extension study for participants completing study NCT06221852.
Conditions
- Bipolar I Disorder
- Schizoaffective Disorder
- Psychosis
Interventions
- OTHER
-
Ketogenic diet
The ketogenic diet (KD) is a normo-caloric diet composed of high-fat, low carbohydrate, and adequate protein intake. The KD will consist of 3 meals a day plus snacks, targeting 75-80% fat, 13-18% protein, 7% carbohydrates.
Sponsors & Collaborators
-
Baszucki Family Foundation
collaborator UNKNOWN -
Mclean Hospital
lead OTHER
Principal Investigators
-
Virginie-Anne Chouinard, MD · Mclean Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-28
- Primary Completion
- 2027-09-30
- Completion
- 2027-12-30
Countries
- United States
Study Locations
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