Bipolar I DisorderNutrition and dietBehavioral
What this study is
This is a 12-week open-label extension study for participants completing study NCT06221852.
What's being tested
- Ketogenic diet
Intervention · OTHER
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.
Study details
- Official title
- Open Label Extension Study of NCT06221852 of the Ketogenic Diet in Participants With First Episode Bipolar Disorder.
- Sponsor
- Mclean Hospital
- Conditions
- Bipolar I Disorder · Schizoaffective Disorder · Psychosis
- Enrolling
- 50 people
- Starts
- 2024-08-28
- Est. completion
- 2027-12-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 45 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Participants who met original entry criteria in, and completed, the randomized 12-week study of NCT06221852.
You can't join if
- No longer meeting original entry criteria from the randomized 12-week study of NCT06221852.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMcLean Hospital
Belmont, Massachusetts, United States
Study team
Sponsor
Mclean Hospital
Study ID 2023P002849-2
Principal investigator
Virginie-Anne Chouinard, MD
Mclean Hospital
Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.