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Behavioural Intervention

Ketogenic Diet for Bipolar Disorder

N/A

Recruiting

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

Between the ages of 18 and 45

Be between 18 and 65 years old

Must not have

History of gastric bypass surgery or any weight loss surgery

Current cancer diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effects of the ketogenic diet, along with standard treatment, on brain energy and mental health symptoms in people with bipolar disorder and schizoaffective disorder who are experiencing their first episode

Who is the study for?

This trial is for individuals experiencing their first episode of bipolar disorder or schizoaffective disorder. Participants should be willing to follow specific dietary guidelines, including a ketogenic diet as part of the study.

What is being tested?

The study is testing how effective a ketogenic diet is when combined with standard treatments in improving brain energy metabolism and reducing psychiatric symptoms in new cases of bipolar and schizoaffective disorders.

What are the potential side effects?

Potential side effects from following a ketogenic diet may include fatigue, headache, dizziness, irritability, nausea, difficulty sleeping, constipation or other digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had weight loss surgery in the past.

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I am currently diagnosed with cancer.

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I have been diagnosed with type 1 or type 2 diabetes.

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I do not have any unstable illnesses affecting my heart, liver, kidneys, lungs, hormones, nervous system, or blood.

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I am unable to understand or sign the consent form.

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My weight is over 350 lbs or my BMI is less than 20.

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I have been diagnosed with familial hypercholesterolemia.

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I am currently being treated with Propofol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

2Treatment groups

Active Control

Group I: Ketogenic diet armActive Control1 Intervention

Eligible participants assigned to the ketogenic diet arm 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 weekly and as needed diet counseling from a registered dietician. Participants will be asked to monitor and report their blood ketone levels each day via a finger-prick device provided by the study team. Participants have the ability to opt into an optional open label phase where they can continue on the ketogenic diet with the daily finger pricks for another 12 weeks after the 12-week main study.

Group II: Dietary Guidelines for Americans armActive Control1 Intervention

Eligible participants assigned to the Dietary Guidelines for Americans (DGA) arm will adhere to the Dietary Guidelines for Americans in addition to any ongoing medications (e.g., mood stabilizers and/or second-generation antipsychotics). Participants will receive weekly and as needed diet counseling from a registered dietician. Participants will be asked to monitor and report their blood ketone levels each day via a finger-prick device provided by the study team. Participants have the ability to opt into an optional open label phase where they can switch to the ketogenic diet with the daily finger pricks for 12 weeks after the 12-week main study.

0 / 9Eligibility criteria met