Clinical trial NCT06558201: Open Label Extension Study of NCT06221852
Official title: Open Label Extension Study of NCT06221852 of the Ketogenic Diet in Participants With First Episode Bipolar Disorder.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Bipolar I Disorder
Schizoaffective Disorder
Psychosis
Keywords: First episode psychosis
Ketogenic diet
Keto
Brain energy metabolism
Insulin resistance
Schizoaffective disorder
Bipolar disorder
Magnetic resonance spectroscopy (MRS)
Redox
Creatine kinase
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Baszucki Family Foundation
First posted: 2024-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will have completed the 12-week randomized controlled trial (NCT06221852), and will follow the ketogenic diet in this open label extension.
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH)
timeFrame: 24 weeks
measure: Change in brain creatine kinase forward reaction rate (kf)
timeFrame: 24 weeks
measure: Change in insulin resistance
timeFrame: 24 weeks
measure: Change in psychotic symptoms
timeFrame: 24 weeks
measure: Change in depressive symptoms
timeFrame: 24 weeks
measure: Change in mania symptoms
timeFrame: 24 weeks
measure: Change in Clinical Global Impression (CGI) Scale
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: 24 weeks
measure: Change in glycated hemoglobin (Hemoglobin A1c) level
timeFrame: 24 weeks
measure: Change in triglyceride levels
timeFrame: 24 weeks
measure: Change in low-density lipoprotein (LDL) levels
timeFrame: 24 weeks
measure: Change in high-density lipoprotein (HDL) levels
timeFrame: 24 weeks
measure: Change in high-sensitivity C-reactive protein (hs-CRP) levels
timeFrame: 24 weeks
measure: Change in brain gamma-aminobutyric acid (GABA) concentration
timeFrame: 24 weeks
measure: Change in brain glutamate metabolite concentration
timeFrame: 24 weeks
measure: Change in brain glutathione (GSH)
timeFrame: 24 weeks
measure: Change in brain Phosphocreatine (PCr)
timeFrame: 24 weeks
measure: Change in brain pH
timeFrame: 24 weeks
measure: Change in brain inorganic phosphate concentration
timeFrame: 24 weeks
measure: Change in adverse events
timeFrame: 24 weeks
measure: Change in anxiety symptoms
timeFrame: 24 weeks
measure: Change in stress symptoms
timeFrame: 24 weeks
measure: Change in cognitive performance
timeFrame: 24 weeks
measure: Change in Global Functioning Scale (GFS) - Social and Role total score
timeFrame: 24 weeks
measure: Change in blood NAD/NADH+ ratio
timeFrame: 24 weeks
measure: Change in blood GSH/GSSH ratio
timeFrame: 24 weeks
measure: Change in growth differentiation factor 15 (GDF15)
timeFrame: 24 weeks
measure: Change in cell-free mitochondrial DNA (cf-mtDNA)
timeFrame: 24 weeks
Other outcomes:
measure: Change in World Health Organization Disability Assessment Schedule (WHODAS) score
timeFrame: 24 weeks
measure: Change in World Health Organization Quality of Life (WHOQOL) score
timeFrame: 24 weeks
measure: Change in Extrapyramidal Symptom Rating Scale (ESRS) total score
timeFrame: 24 weeks
measure: Change in Pittsburgh Sleep Quality Index (PSQI) total score
timeFrame: 24 weeks
measure: Change in resting-state fMRI
timeFrame: 24 weeks
measure: Change in gray matter volume
timeFrame: 24 weeks
measure: Change in cortical surface area
timeFrame: 24 weeks
measure: Change in white matter fractional anisotropy (FA)
timeFrame: 24 weeks
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Virginie-Anne Chouinard, MD
role: PRINCIPAL_INVESTIGATOR
References: