Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
This study is a randomized clinical trial looking at how a ketogenic diet, along with your usual treatment, affects brain energy and symptoms in people with first-episode bipolar I disorder or schizoaffective disorder. It compares the ketogenic diet (high fat, low carb) to the Dietary Guidelines for Americans diet (a standard healthy diet). Researchers will measure changes in brain energy markers (like NAD+/NADH ratio and creatine kinase) and insulin resistance after 12 weeks to see if the ketogenic diet is helpful. You may be able to join if you are 18-45 years old, have a recent diagnosis of bipolar I disorder or schizoaffective disorder, and can follow one of the study diets. The current recruitment status is unclear.
- Study design
- This is a randomized controlled trial aiming to enroll 50 participants. It compares a ketogenic diet to a standard diet.
- What's involved
- You would follow a specific diet (either ketogenic or standard) for 12 weeks. The study will involve measurements of brain energy and metabolic markers.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 weeks, which is when the primary outcomes are measured.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Virginie-Anne Chouinard, MD · PRINCIPAL_INVESTIGATOR · Mclean Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH)12 weeks
Change from baseline to week 12 in NAD+/NADH as measured by in vivo phosphorus magnetic resonance spectroscopy (31P-MRS).
- Change in brain creatine kinase forward reaction rate (kf)12 weeks
Change from baseline to week 12 in creatine kinase forward reaction rate (kf) as measured by 31P magnetization transfer (MT) MRS.
- Change in insulin resistance12 weeks
Change from baseline to week 12 of insulin resistance measured using the homeostatic model assessment of insulin resistance (HOMA-IR) using fasting blood glucose and insulin levels.
- Change in psychotic symptoms12 weeks
Change from baseline to week 12 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 depressive symptoms12 weeks
Change from baseline to week 12 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 mania symptoms12 weeks
Change from baseline to week 12 in Young Mania Rating Scale (YMRS) total score. Scores range from 0-60. A higher score indicates a more severe illness.
- Change in Clinical Global Impression (CGI) Scale12 weeks
Change from baseline to week 12 in Clinical Global Impression (CGI) Scale. Scores range from 1-7; a higher score indicates higher severity of illness.