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Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

StatusRecruiting
PhaseNot applicable
Started2024-03-12
View on ClinicalTrials.gov ↗

Amendment history

2026-08-13
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 1 site
2025-11-04
Study Status v5
Re-verified, no change to tracked fields
2024-08-14
Study Status, Arms and Interventions, Outcome Measures v4
Secondary endpoints17 to 21 entries
Change in cell-free mitochondrial DNA (cf-mtDNA) Change in growth differentiation factor 15 (GDF15) Change in blood NAD/NADH+ ratio Change in blood GSH/GSSH ratio
2024-04-02
Study Status v3
Start dateestimated 2024-03-05→confirmed 2024-03-12
2024-03-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-09→2027-09-30
Completion date2027-12→2027-12-30
Start date2024-03→2024-03-05
Study sitesdetails revised at 1 of 1 site
2024-02-15
Study Status, Study Description, Outcome Measures v1
Primary completion date2027-01-14→2027-09
Completion date2027-03-14→2027-12
Start date2024-01-14→2024-03
Secondary endpoints16 to 17 entries
Change in brain potential of hydrogenglutathione (GSH) Change in brain pH)
Study description+46 characters
Several lines of evidence show energy metabolism and redox dysfunctiondysregulation in bipolar disorder and psychotic disorders. Ketogenic inte [...] ntrolled trial will assess the benefits of a ketogenic diet intervention in combination with treatment as usual compared to a standard diet. Investigators will measure the effects of anutritional ketogenic interventionketosis on brain redox and energy metabolism and other neurometabolic markers using phosphorus magnetic resonance spectroscopy (31P-MRS). Furthermore, investigators will measure the effects of the ketogenic diet on mood and psychotic sympt [...] [...]
2024-01-23
Original filing
This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.
Trial Details
NCT Number NCT06221852
Lead Sponsor Mclean Hospital
Collaborators: Baszucki Family Foundation
Conditions Bipolar I Disorder, Psychosis, Schizoaffective Disorder
Enrollment 50 participants
Start Date 2024-03-12
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-17