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Ketogenic Diet for Mental Illness

N/A

Waitlist Available

Led By Virginie-Anne Chouinard, MD

Research Sponsored by Mclean Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is an extension of a previous study and will last for 12 weeks.

Who is the study for?

This trial is for individuals who have completed the initial 12-week study NCT06221852 and still meet the original criteria. It's aimed at those with conditions like schizoaffective disorder, psychosis, mental illness, or bipolar disorder.

What is being tested?

Participants will continue to follow a ketogenic diet over an additional 12 weeks. This extension of the previous study allows researchers to gather more data on its long-term effects in managing psychiatric disorders.

What are the potential side effects?

While not specified here, typical side effects of a ketogenic diet may include flu-like symptoms (often called 'keto flu'), digestive discomfort, changes in energy levels, nutrient deficiencies if not properly managed, and potential cholesterol level changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Clinical Global Impression (CGI) Scale

Change in brain creatine kinase forward reaction rate (kf)

Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH)

+4 more

Secondary study objectives

Change in Global Functioning Scale (GFS) - Social and Role total score

Change in adverse events

Change in anxiety symptoms

+18 more

Other study objectives

Change in Extrapyramidal Symptom Rating Scale (ESRS) total score

Change in Pittsburgh Sleep Quality Index (PSQI) total score

Change in World Health Organization Disability Assessment Schedule (WHODAS) score

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketogenic dietExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out