McLean Hospital
Belmont, Massachusetts, 02487, United States
NCT Number: NCT06558201
This is a 12-week open-label extension study for participants completing study NCT06221852.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Belmont, Massachusetts, 02487, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-No longer meeting original entry criteria from the randomized 12-week study of NCT06221852.
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.
Other names: Keto diet
Time frame: 24 weeks
Change from baseline to week 24 in NAD+/NADH as measured by in vivo phosphorus magnetic resonance spectroscopy (31P-MRS).
Time frame: 24 weeks
Change from baseline to week 24 in creatine kinase forward reaction rate (kf) as measured by 31P magnetization transfer (MT) MRS.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks
Change from baseline to week 24 in participant body weight in kilograms, as measured using a standing scale.
Time frame: 24 weeks
Change from baseline to week 24 in fasting Hemoglobin A1c level.
Time frame: 24 weeks
Change from baseline to week 24 in fasting triglyceride levels.
Time frame: 24 weeks
Change from baseline to week 24 in fasting LDL levels
Time frame: 24 weeks
Change from baseline to week 24 in fasting HDL levels
Time frame: 24 weeks
Change from baseline to week 24 in fasting hs-CRP levels.
Time frame: 24 weeks
Change from baseline to week 24 in GABA concentration measured by proton magnetic resonance spectroscopy.
Time frame: 24 weeks
Change from baseline to week 24 in glutamate metabolite concentration measured by proton magnetic resonance spectroscopy.
Time frame: 24 weeks
Change from baseline to week 24 in brain GSH measured by proton magnetic resonance spectroscopy.
Time frame: 24 weeks
Changes from baseline to week 24 in PCr concentration as measured by in vivo 31P-MRS.
Time frame: 24 weeks
Change from baseline to week 24 in pH as measured by in vivo 31P MRS
Time frame: 24 weeks
Change from baseline to week 24 in inorganic phosphate (Pi) concentration as measured by in vivo 31P MRS.
Time frame: 24 weeks
Change from baseline to week 24 in adverse events.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks
Change from baseline to week 24 in blood NAD/NADH+ ratio.
Time frame: 24 weeks
Change from baseline to week 24 in blood GSH/GSSH ratio.
Time frame: 24 weeks
Change from baseline to week 24 in blood and saliva GDF15 levels.
Time frame: 24 weeks
Change from baseline to week 24 in blood and saliva cf-mtDNA levels.
Time frame: 24 weeks
Change from baseline to week 24 in World Health Organization Disability Assessment Schedule (WHODAS) scale. Scores range from 0-144. A higher score indicates greater dysfunction and disability in major life domains.
Time frame: 24 weeks
Change from baseline to week 24 in World Health Organization Quality of Life (WHOQOL) scale. Scores range from 1-130. A lower score indicates lower perceived quality of life.
Time frame: 24 weeks
Change from baseline to week 24 in Extrapyramidal Symptom Rating Scale (ESRS) total score. Scores range from 0-102; a higher score indicates more severe symptoms.
Time frame: 24 weeks
Change from baseline to week 24 in Pittsburgh Sleep Quality Index (PSQI) total score. Scores range from 0-21; a higher score indicates worse sleep quality.
Time frame: 24 weeks
Change within network positive correlations and between network negative correlations from baseline to week 24.
Time frame: 24 weeks
Change in the gray matter volumes (cubic millimeters) of the frontal, parietal and temporal lobes as defined by Freesurfer's Desikan-Killiany Brain Atlas from baseline to week 24.
Time frame: 24 weeks
Change in the cortical surface area (millimeters squared) of the frontal, parietal and temporal lobes as defined by Freesurfer's Desikan-Killiany Brain Atlas from baseline to week 24.
Time frame: 24 weeks
Change in fractional anisotropy (FA), a scalar measure of diffusivity, of water in the brain assessed by DTI at 3T from baseline to week 24. FA values range from 0 (isotropic, meaning diffusion is equally restricted in 3D space) to 1 (anisotrophic, meaning that diffusion is completely restricted to a single direction).
Mclean Hospital
Other
Open Label Extension Study of NCT06221852 of the Ketogenic Diet in Participants With First Episode Bipolar Disorder.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06221852
Bipolar Disorder, Bipolar I Disorder
Belmont, Massachusetts, United States
View Trial DetailsNCT07116694
Aberrant Motor Behavior in Dementia, Behavior
Chino, California, United States
View Trial DetailsNCT03919760
Affective Disorders, Psychotic, Behavior
Greater Sudbury, Ontario, Canada
View Trial DetailsNCT05658510
Aberrant Motor Behavior in Dementia, Agitation,Psychomotor
Bellflower, California, United States
View Trial Details