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

Mclean Hospital

Summary

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

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.

Eligibility

Age range: 18–45 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Participants who met original entry criteria in, and completed, the randomized 12-week study of NCT06221852. Exclusion Criteria: -No longer meeting original entry criteria from the randomized 12-week study of NCT06221852.

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.

Location

McLean Hospital
Belmont, Massachusetts