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Behavioural Intervention

Ketogenic diet arm for Psychosis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 45 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Change in adverse events

Change in anxiety symptoms

+14 more

Other outcome measures

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

+1 more

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.

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor

213 Previous Clinical Trials

21,644 Total Patients Enrolled

8 Trials studying Psychosis

957 Patients Enrolled for Psychosis

Baszucki Family FoundationUNKNOWN

Virginie-Anne Chouinard, MDPrincipal InvestigatorMclean Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 45 eligible to participate in this medical study?

"To be eligible for participation in this clinical trial, individuals must be at least 18 years old and no older than 45 years."

Answered by AI

What is the primary objective of this clinical trial endeavor?

"The primary goal of this clinical trial, which will be assessed over a period of approximately 12 weeks, is to observe changes in symptoms associated with mania. Secondary objectives include assessing changes in low-density lipoprotein (LDL) levels, measured by the difference between baseline and week 12 fasting LDL levels; monitoring changes in body weight, determined by the difference between baseline and week 12 participant body weight measured using a standing scale; and evaluating changes in anxiety symptoms as indicated by variations in Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline to week 12. The HAM-A scale ranges from 0 to 56"

Answered by AI

Are there still available slots for patients to participate in this ongoing clinical trial?

"As per the information available on clinicaltrials.gov, this particular clinical trial is not actively recruiting participants. Although it was initially posted on January 14th, 2024 and last edited on January 23rd, 2024. However, there are currently a total of 582 other studies that are actively enrolling participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

Virginie-Anne Chouinard, MD 2024. "Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06221852.

All > Paid Studies Boston