NCT06558201

Open Label Extension Study of NCT06221852

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar I Disorder
• Schizoaffective Disorder
• Psychosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-28
• Primary completion: 2027-09-30
• Completion: 2027-12-30
• First posted: 2024-08-16
• Last updated: 2025-04-17

Locations

1 site across 1 country: United States