Open Label Extension Study of NCT06221852

Mass General Brigham

Status: Invitation-only

Conditions: Psychosis; Bipolar I Disorder; Schizoaffective Disorder

Treatments: Other: Ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06558201

2023P002849-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Ketogenic diet

Experimental group

Description:

Participants will be asked to follow the ketogenic diet (KD) for 12 weeks in addition to any ongoing medications (e.g., mood stabilizers and/or second-generation antipsychotics). Participants will receive diet counseling from a registered dietitian. Participants will be asked to monitor and report their blood ketone and glucose levels each day via a finger-prick device provided by the study team.

Treatment:

Other: Ketogenic diet