Open Label Extension Study of NCT06221852
- Conditions
- Bipolar I DisorderSchizoaffective DisorderPsychosis
- Interventions
- Other: Ketogenic diet
- Registration Number
- NCT06558201
- Lead Sponsor
- Mclean Hospital
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50
- Participants who met original entry criteria in, and completed, the randomized 12-week study of NCT06221852.
-No longer meeting original entry criteria from the randomized 12-week study of NCT06221852.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ketogenic diet Ketogenic diet 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.
- Primary Outcome Measures
Name Time Method Change in depressive symptoms 24 weeks Change from baseline to week 24 in Hamilton Rating Scale for Depression (HAM-D) total score. Scores range from 0-52; a higher score indicates a higher level of depression.
Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH) 24 weeks Change from baseline to week 24 in NAD+/NADH as measured by in vivo phosphorus magnetic resonance spectroscopy (31P-MRS).
Change in psychotic symptoms 24 weeks Change from baseline to week 24 in Positive and Negative Syndrome Scale (PANSS) total score. Scores range from 30-210; a higher score indicates a higher level of psychotic symptoms.
Change in Clinical Global Impression (CGI) Scale 24 weeks Change from baseline to week 24 in Clinical Global Impression (CGI) Scale. Scores range from 1-7; a higher score indicates higher severity of illness.
Change in brain creatine kinase forward reaction rate (kf) 24 weeks Change from baseline to week 24 in creatine kinase forward reaction rate (kf) as measured by 31P magnetization transfer (MT) MRS.
Change in mania symptoms 24 weeks Change from baseline to week 24 in Young Mania Rating Scale (YMRS) total score. Scores range from 0-60. A higher score indicates a more severe illness.
Change in insulin resistance 24 weeks Change from baseline to week 24 of insulin resistance measured using the homeostatic model assessment of insulin resistance (HOMA-IR) using fasting blood glucose and insulin levels.
- Secondary Outcome Measures
Name Time Method Change in blood GSH/GSSH ratio 24 weeks Change from baseline to week 24 in blood GSH/GSSH ratio.
Change in high-sensitivity C-reactive protein (hs-CRP) levels 24 weeks Change from baseline to week 24 in fasting hs-CRP levels.
Change in high-density lipoprotein (HDL) levels 24 weeks Change from baseline to week 24 in fasting HDL levels
Change in brain glutathione (GSH) 24 weeks Change from baseline to week 24 in brain GSH measured by proton magnetic resonance spectroscopy.
Change in brain pH 24 weeks Change from baseline to week 24 in pH as measured by in vivo 31P MRS
Change in glycated hemoglobin (Hemoglobin A1c) level 24 weeks Change from baseline to week 24 in fasting Hemoglobin A1c level.
Change in brain glutamate metabolite concentration 24 weeks Change from baseline to week 24 in glutamate metabolite concentration measured by proton magnetic resonance spectroscopy.
Change in stress symptoms 24 weeks Change from baseline to week 24 in Depression Anxiety Stress Scales (DASS-42) Stress Subscale score. Scores range from 0-42; a higher score indicates a higher level of stress.
Change in low-density lipoprotein (LDL) levels 24 weeks Change from baseline to week 24 in fasting LDL levels
Change in brain gamma-aminobutyric acid (GABA) concentration 24 weeks Change from baseline to week 24 in GABA concentration measured by proton magnetic resonance spectroscopy.
Change in brain Phosphocreatine (PCr) 24 weeks Changes from baseline to week 24 in PCr concentration as measured by in vivo 31P-MRS.
Change in anxiety symptoms 24 weeks Change from baseline to week 24 from baseline to week 12 in Hamilton Anxiety Rating Scale (HAM-A) total score. Scores range from 0 - 56; a higher score indicates a higher level of anxiety.
Change in body weight 24 weeks Change from baseline to week 24 in participant body weight in kilograms, as measured using a standing scale.
Change in triglyceride levels 24 weeks Change from baseline to week 24 in fasting triglyceride levels.
Change in brain inorganic phosphate concentration 24 weeks Change from baseline to week 24 in inorganic phosphate (Pi) concentration as measured by in vivo 31P MRS.
Change in adverse events 24 weeks Change from baseline to week 24 in adverse events.
Change in cognitive performance 24 weeks Change from baseline to week 24 in Matrics Consensus Cognitive Battery (MCCB) Total Score. Scores range from 0.00% - 100.00%; a higher score indicates higher cognition.
Change in Global Functioning Scale (GFS) - Social and Role total score 24 weeks Change from baseline to week 24 in Global Functioning Scale (GFS) - Social and Role total score. Scores range from 6-60; a lower score indicates worse social and role functioning.
Change in blood NAD/NADH+ ratio 24 weeks Change from baseline to week 24 in blood NAD/NADH+ ratio.
Change in growth differentiation factor 15 (GDF15) 24 weeks Change from baseline to week 24 in blood and saliva GDF15 levels.
Change in cell-free mitochondrial DNA (cf-mtDNA) 24 weeks Change from baseline to week 24 in blood and saliva cf-mtDNA levels.
Trial Locations
- Locations (1)
McLean Hospital
🇺🇸Belmont, Massachusetts, United States