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Ketogenic Diet for Bipolar Disorder

N/A

Recruiting

Led By Mary Phillips, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

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

Must have

All participants: 18-30 years of age

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up scan 3 at end of second dietary phase (8-10 weeks) (participants with bipolar disorder)

Awards & highlights

Study Summary

This trial looks at how a keto diet affects brain, metabolism, and emotions in adults with Bipolar Disorder.

Who is the study for?

Adults aged 18-30 with Bipolar Disorder, either hypomanic or euthymic, who are taking certain BD medications can join. Healthy controls without psychiatric history are also needed. Exclusions include head injury, systemic diseases, substance abuse (except limited cannabis), poor English understanding, and specific medical conditions.Check my eligibility

What is being tested?

The trial is testing the effects of a ketogenic diet versus no diet change or a non-ketogenic diet on brain function and mood in people with Bipolar Disorder. Participants will be monitored to see how their brain activity and emotional state respond to dietary changes.See study design

What are the potential side effects?

Potential side effects from the ketogenic diet may include digestive discomfort, changes in energy levels, nutrient deficiencies if not properly managed, and possible exacerbation of existing health issues related to pancreas, liver, thyroid or gallbladder.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 30 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (all participants)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (all participants)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (all participants) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Blood oxygen level-dependent (BOLD) signal at Scan 1

Blood oxygen level-dependent (BOLD) signal at Scan 2

Blood oxygen level-dependent (BOLD) signal at Scan 3

+42 more

Secondary outcome measures

Average rest-activity rhythm interdaily stability during Ketogenic vs Normal diet

Average total sleep time during Ketogenic vs Normal diet

Ecological momentary assessments (EMA) during the first dietary phase: Energy monitoring

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: No dietExperimental Treatment1 Intervention

Participants without Bipolar Disorder will not participate in the diet phases of the study

Group II: 1st phase Non-ketogenic Diet / 2nd phase Ketogenic DietExperimental Treatment2 Interventions

Participants with Bipolar Disorder will consume a non-ketogenic diet for the first phase of the study and then a ketogenic diet for the second phase of the study

Group III: 1st phase Ketogenic Diet / 2nd phase Non-ketogenic DietExperimental Treatment2 Interventions

Participants with Bipolar Disorder will consume a ketogenic diet for the first phase of the study and then a non-ketogenic diet for the second phase of the study

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,723 Previous Clinical Trials

16,342,849 Total Patients Enrolled

27 Trials studying Bipolar Disorder

5,642 Patients Enrolled for Bipolar Disorder

Baszucki Brain Research FundOTHER

6 Previous Clinical Trials

208 Total Patients Enrolled

5 Trials studying Bipolar Disorder

198 Patients Enrolled for Bipolar Disorder

Mary Phillips, MDPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

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

Does this research initiative admit participants who are twenty or older?

"As specified in the enrollment qualifications, individuals between 18 and 30 years old are eligible to partake in this clinical trial."

Answered by AI

Is it possible for me to take part in this scientific experiment?

"Eligibility for this trial necessitates that participants are diagnosed with bipolar disorder and between the ages of eighteen to thirty. As of now, 107 people have been recruited."

Answered by AI

Are applicants currently being accepted for the clinical trial?

"Information available on clinicaltrials.gov denotes that this trial is no longer recruiting patients, having last been modified on October 5th 2023 after initially being posted January 1st 2024. Despite not accepting new participants at this time, there are a total of 163 other trials open to enrolment currently."

Answered by AI

What outcomes are anticipated from this experiment?

"The purpose of this study, which will assess data collected over the Baseline Scan 1 timeframe, is to measure Blood oxygen level-dependent (BOLD) signal at Scan 2. Secondary objectives incorporate Average rest-activity rhythm interdaily stability during Ketogenic vs Normal diet using wrist actigraphy. In addition, Ecological momentary assessments (EMA), such as Mood and Energy monitoring on a scale from 1 to 7 with correspondingly low or high values respectively, are also being conducted for participants with Bipolar disorder during the first dietary phase."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)

Mary Phillips, MD MD (Cantab) 2024. "Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06081426.

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