Open Label Extension Study of NCT06221852
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketogenic diet.
- Who it may be relevant to
- Registry conditions: Bipolar I Disorder, Schizoaffective Disorder, Psychosis. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Open Label Extension Study of NCT06221852 of the Ketogenic Diet in Participants With First Episode Bipolar Disorder.
Overview
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.
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.
Primary outcome measures
- Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH) [Time frame: 24 weeks]
- Change in brain creatine kinase forward reaction rate (kf) [Time frame: 24 weeks]
- Change in insulin resistance [Time frame: 24 weeks]
- Change in psychotic symptoms [Time frame: 24 weeks]
- Change in depressive symptoms [Time frame: 24 weeks]
- Change in mania symptoms [Time frame: 24 weeks]
- Change in Clinical Global Impression (CGI) Scale [Time frame: 24 weeks]
Secondary outcome measures (12)
- Change in body weight [Time frame: 24 weeks]
- Change in glycated hemoglobin (Hemoglobin A1c) level [Time frame: 24 weeks]
- Change in triglyceride levels [Time frame: 24 weeks]
- Change in low-density lipoprotein (LDL) levels [Time frame: 24 weeks]
- Change in high-density lipoprotein (HDL) levels [Time frame: 24 weeks]
- Change in high-sensitivity C-reactive protein (hs-CRP) levels [Time frame: 24 weeks]
- Change in brain gamma-aminobutyric acid (GABA) concentration [Time frame: 24 weeks]
- Change in brain glutamate metabolite concentration [Time frame: 24 weeks]
- Change in brain glutathione (GSH) [Time frame: 24 weeks]
- Change in brain Phosphocreatine (PCr) [Time frame: 24 weeks]
- Change in brain pH [Time frame: 24 weeks]
- Change in brain inorganic phosphate concentration [Time frame: 24 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- McLean Hospital — Belmont
Identifiers
NCT: NCT06558201 · 2023P002849-2