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ENROLLING BY INVITATION
NCT06558201
NA

Open Label Extension Study of NCT06221852

Sponsor: Mclean Hospital

View on ClinicalTrials.gov

Summary

This is a 12-week open-label extension study for participants completing study NCT06221852.

Official title: Open Label Extension Study of NCT06221852 of the Ketogenic Diet in Participants With First Episode Bipolar Disorder.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-08-28

Completion Date

2027-12-30

Last Updated

2025-04-17

Healthy Volunteers

No

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.

Locations (1)

McLean Hospital

Belmont, Massachusetts, United States