Bipolar DisorderNCT06081426
Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)
A study testing Non-ketogenic Diet, Ketogenic Diet and No diet in people with Bipolar Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Non-ketogenic Diet, Ketogenic Diet and No diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants:
- 18-40 years of age
- Not following a ketogenic diet
- BD hypomanic group (n=30):
- Meeting sex proportion: 50% female
- Meeting diagnosis proportion: 50:50% Bipolar I: Bipolar II (BDI:II) (Diagnostic and Statistical Manual of Mental Disorders 5; DSM-5)
Show all 16Show fewer
- Score greater than 10 on the Young Mania Rating Scale score(YMRS)
- BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)
- BD euthymic group (n=30):
- Meeting sex proportion: 50% female
- Meeting diagnosis proportion: 50:50% BDI:II (DSM-5)
- Score less than or equal to 10 on YMRS
- BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)
- Healthy Control (HC) Group (n=30):
- Sex matched with BD groups
- No psychiatric history
Who cannot join
- All participants:
- Not between 18-40 years of age
- History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report)
- Mini-Mental State Examination score (cognitive state) <24
- Premorbid National Adult Reading Test Intelligent Quotient (NAART IQ) estimate<85
- Visual disturbance: <20/40 Snellen visual acuity
Show all 31Show fewer
- History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (SCID-5). Note: lifetime/present cannabis use (at non-abuse (<3 times in the past month) and non SUD levels) will be allowed, given its common usage in BD and young adults. Cannabis SUD over the last 6 months will not be allowed. Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals
- MRI exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy
- Unable to understand English
- Conditions related to the pancreas, liver, thyroid or gallbladder.
- Taking anticoagulants and/or those with blood dyscrasias (illnesses) who have coagulation disorders (eg, hemophilia) because of the ketomojo finger stick blood tests
- Scoring 3 or higher on positive symptom factor questions on the Positive and Negative Syndrome Scale (PANSS) questionnaire (indicative of psychotic symptoms)
- Currently following a ketogenic diet
- Head circumference larger than 24 inches (62cm) and/or chest circumference larger than 55 inches (139 cm)
- BD hypomanic group:
- Must be meeting sex proportions: not 50% female
- Must be meeting diagnosis proportions: not 50:50% BDI:II (DSM-5)
- Diagnosis of BD in a manic or euthymic episode
- Score 10 or lower on the Young Mania Rating Scale score(YMRS)
- Using psychotropic medications other than those allowed in inclusion criteria
- Does not have a smartphone with a) iOS version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app
- BD euthymic group:
- Not meeting sex proportion: not 50% female
- Not meeting diagnosis proportion: not 50:50% BDI:II
- Diagnosis of BD in a depressive, hypomanic, or manic episode
- Score greater than 10 on YMRS
- Using psychotropic medications other than those allowed in inclusion criteria
- Does not have a smartphone with a) iOS version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app
- Healthy Control (HC) Group
- Not sex-matched with BD groups
- Has psychiatric history
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Jill Morris-Tillman, 412-383-8206, morristillmanje@upmc.edu
Mary L Phillps, MD, MD
About this study
Official title: Elucidating Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD): a Multidisciplinary Mechanistic Study
The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).
Read the detailed description
The investigators hypothesize that a ketogenic diet will enhance levels of the ketone body β-Hydroxybutyrate (beta OHB), resulting in reduced mania/hypomania severity and predisposition to mania/hypomania in individuals with BD. To test this hypothesis in depth, the investigators will use a novel, multidisciplinary mechanistic study using multimodal neuroimaging, peripheral markers of mitochondrial metabolism, and participant-derived induced pluripotent stem cell (iPSC)-derived organoids.
- Conditions
- Bipolar Disorder
- Being tested
- Non-ketogenic Diet, Ketogenic Diet, No diet
- Keywords
- Ketogenic Diet, Magnetic Resonance Imaging
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-ketogenic DietOther
Consuming a non-ketogenic diet
Ketogenic DietOther
Consuming a ketogenic diet
No dietOther
Participants without Bipolar Disorder will not participate in the diet phases of the study
| Study group | Role | What they receive |
|---|---|---|
| 1st phase Non-ketogenic Diet / 2nd phase Ketogenic Diet | Experimental | 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 Receives: Other: Non-ketogenic Diet; Other: Ketogenic Diet |
| 1st phase Ketogenic Diet / 2nd phase Non-ketogenic Diet | Experimental | 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 Receives: Other: Non-ketogenic Diet; Other: Ketogenic Diet |
| No diet | Other | Participants without Bipolar Disorder will not participate in the diet phases of the study Receives: Other: No diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen level-dependent (BOLD) signal at Scan 1
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Measured: Baseline Scan 1 (all participants)
Blood oxygen level-dependent (BOLD) signal at Scan 2
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Measured: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Blood oxygen level-dependent (BOLD) signal at Scan 3
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Measured: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Manic symptoms at Scan 1
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Measured: Baseline Scan 1 (all participants)
Manic symptoms at Scan 2
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Measured: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Manic symptoms at Scan 3
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Measured: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting Glucose at Baseline
Fasting glucose blood levels
Measured: Baseline (all participants)
Fasting lipids at Baseline
Fasting lipid blood levels
Measured: Baseline (all participants)
Fasting hepatic function panel at Baseline: total protein
Fasting levels of total protein in the blood
Measured: Baseline (all participants)
Fasting hepatic function panel at Baseline: albumin
Fasting levels of albumin in the blood
Measured: Baseline (all participants)
Fasting hepatic function panel at Baseline: bilirubin
Fasting levels of bilirubin in the blood
Measured: Baseline (all participants)
Fasting hepatic function panel at Baseline: liver enzyme
Fasting levels of liver enzyme in the blood
Measured: Baseline (all participants)
Fasting Glucose at halfway point through first dietary phase
Fasting glucose blood levels
Measured: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting lipids at halfway point through first dietary phase
Fasting lipid blood levels
Measured: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through first dietary phase: total protein
Fasting levels of total protein in the blood
Measured: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through first dietary phase: albumin
Fasting levels of albumin in the blood
Measured: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through first dietary phase: bilirubin
Fasting levels of bilirubin in the blood
Measured: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through first dietary phase: liver enzyme
Fasting levels of liver enzyme in the blood
Measured: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting Glucose at end of first dietary phase
Fasting glucose blood levels
Measured: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting lipids at end of first dietary phase
Fasting lipid blood levels
Measured: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of first dietary phase: total protein
Fasting levels of total protein in the blood
Measured: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of first dietary phase: albumin
Fasting levels of albumin in the blood
Measured: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of first dietary phase: bilirubin
Fasting levels of bilirubin in the blood
Measured: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of first dietary phase: liver enzyme
Fasting levels of liver enzyme in the blood
Measured: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting Glucose at halfway point through second dietary phase
Fasting glucose blood levels
Measured: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting lipids at halfway point through second dietary phase
Fasting lipid blood levels
Measured: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through second dietary phase: total protein
Fasting levels of total protein in the blood
Measured: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through second dietary phase: albumin
Fasting levels of albumin in the blood
Measured: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through second dietary phase: bilirubin
Fasting levels of bilirubin in the blood
Measured: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through second dietary phase: liver enzyme
Fasting levels of liver enzyme in the blood
Measured: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting Glucose at end of second dietary phase
Fasting glucose blood levels
Measured: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting lipids at end of second dietary phase
Fasting lipids blood levels
Measured: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of second dietary phase: total protein
Fasting levels of total protein in the blood
Measured: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of second dietary phase: albumin
Fasting levels of albumin in the blood
Measured: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of second dietary phase: bilirubin
Fasting levels of bilirubin in the blood
Measured: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of second dietary phase: liver enzyme
Fasting levels of liver enzyme in the blood
Measured: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Gamma-aminobutyric acid (GABA) at Baseline
Gamma-aminobutyric acid (GABA) concentrations in the brain
Measured: Baseline Scan 1 (all participants)
Glutamate at Baseline
Glutamate concentrations in the brain
Measured: Baseline Scan 1 (all participants)
Lactate at Baseline
Lactate concentrations in the brain
Measured: Baseline Scan 1 (all participants)
Gamma-aminobutyric acid (GABA) at end of first dietary phase
Gamma-aminobutyric acid (GABA) concentrations in the brain
Measured: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Glutamate at end of first dietary phase
Glutamate concentrations in the brain
Measured: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Lactate at end of first dietary phase
Lactate concentrations in the brain
Measured: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Gamma-aminobutyric acid (GABA) at end of second dietary phase
Gamma-aminobutyric acid (GABA) concentrations in the brain
Measured: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Glutamate at end of second dietary phase
Glutamate concentrations in the brain
Measured: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Lactate at end of second dietary phase
Lactate concentrations in the brain
Measured: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Secondary outcomes (8)
Average total sleep time during Ketogenic vs Normal diet
Total sleep time will be assessed using wrist actigraphy. Wrist actigraphy will be collected continuously, at-home.
Measured: Wrist actigraphy will be collected throughout the 8-10wk ketogenic diet and normal diet study intervals
Average rest-activity rhythm interdaily stability during Ketogenic vs Normal diet
Rest-activity rhythm interdaily stability will be assessed using wrist actigraphy. Wrist actigraphy will be collected continuously, at-home
Measured: Wrist actigraphy will be collected throughout the 8-10 wk ketogenic diet and normal diet study intervals.
Ecological momentary assessments (EMA) during the first dietary phase: Mood monitoring
Mood monitoring in real time in participants with Bipolar Disorder: rate mood on a scale of 1-7 with 1 being very low mood and 7 being very high mood
Measured: The first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Ecological momentary assessments (EMA) during the first dietary phase: Energy monitoring
Energy monitoring in real time in participants with Bipolar Disorder: rate energy on a scale of 1-7 with 1 being very low energy and 7 being very high energy
Measured: The first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Ecological momentary assessments (EMA) during the first dietary phase: Suicidality monitoring
Suicidality monitoring in real time in participants with Bipolar Disorder: answer yes or no to having self-harm/suicide thoughts and plans
Measured: The first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Ecological momentary assessments (EMA) during the second dietary phase: Mood monitoring
Mood monitoring in real time in participants with Bipolar Disorder: rate mood on a scale of 1-7 with 1 being very low mood and 7 being very high mood
Measured: The second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Ecological momentary assessments (EMA) during the second dietary phase: Energy monitoring
Energy monitoring in real time in participants with Bipolar Disorder: rate energy on a scale of 1-7 with 1 being very low energy and 7 being very high energy
Measured: The second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Ecological momentary assessments (EMA) during the second dietary phase: Suicidality monitoring
Suicidality monitoring in real time in participants with Bipolar Disorder: answer yes or no to having self-harm/suicide thoughts and plans
Measured: The second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start12 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Baszucki Brain Research Fund
- Responsible party
- Principal investigator, Mary Phillips, MD MD (Cantab), University of Pittsburgh
- Investigators
- Mary Phillips, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081426
- Sponsor's protocol ID
- STUDY23080048
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Informed consent will be collected from study participants that allows for broad sharing of participants' de-identified data. Data transfer procedures will be in accordance with all Institutional Review Board guidelines and federal regulations including HIPAA (Health Insurance Portability and Accountability Act of 1996).
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD): a Multidisciplinary Mechanistic Study
- ClinicalTrials.gov ID
- NCT06081426
- Acronym / sponsor ID
- STUDY23080048
- Conditions
- Bipolar Disorder
- Keywords
- Ketogenic Diet, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Baszucki Brain Research Fund
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).
Detailed description
The investigators hypothesize that a ketogenic diet will enhance levels of the ketone body β-Hydroxybutyrate (beta OHB), resulting in reduced mania/hypomania severity and predisposition to mania/hypomania in individuals with BD. To test this hypothesis in depth, the investigators will use a novel, multidisciplinary mechanistic study using multimodal neuroimaging, peripheral markers of mitochondrial metabolism, and participant-derived induced pluripotent stem cell (iPSC)-derived organoids.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1st phase Non-ketogenic Diet / 2nd phase Ketogenic Diet | Experimental | Other: Non-ketogenic Diet, Other: Ketogenic DietParticipants 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 |
| 1st phase Ketogenic Diet / 2nd phase Non-ketogenic Diet | Experimental | Other: Non-ketogenic Diet, Other: Ketogenic DietParticipants 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 |
| No diet | Other | Other: No dietParticipants without Bipolar Disorder will not participate in the diet phases of the study |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 18-40 years of age
- Not following a ketogenic diet
- Meeting sex proportion: 50% female
- Meeting diagnosis proportion: 50:50% Bipolar I: Bipolar II (BDI:II) (Diagnostic and Statistical Manual of Mental Disorders 5; DSM-5)
- Score greater than 10 on the Young Mania Rating Scale score(YMRS)
Key exclusion criteria (31 listed)
- Not between 18-40 years of age
- History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report)
- Mini-Mental State Examination score (cognitive state) <24
- Premorbid National Adult Reading Test Intelligent Quotient (NAART IQ) estimate<85
- Visual disturbance: <20/40 Snellen visual acuity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-ketogenic DietConsuming a non-ketogenic diet | Other | 1st phase Ketogenic Diet / 2nd phase Non-ketogenic Diet, 1st phase Non-ketogenic Diet / 2nd phase Ketogenic Diet |
| Ketogenic DietConsuming a ketogenic diet | Other | 1st phase Ketogenic Diet / 2nd phase Non-ketogenic Diet, 1st phase Non-ketogenic Diet / 2nd phase Ketogenic Diet |
| No dietParticipants without Bipolar Disorder will not participate in the diet phases of the study | Other | No diet |
Primary outcome
Blood oxygen level-dependent (BOLD) signal at Scan 1
Time frame: Baseline Scan 1 (all participants)
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Blood oxygen level-dependent (BOLD) signal at Scan 2
Time frame: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Blood oxygen level-dependent (BOLD) signal at Scan 3
Time frame: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Manic symptoms at Scan 1
Time frame: Baseline Scan 1 (all participants)
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Manic symptoms at Scan 2
Time frame: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Manic symptoms at Scan 3
Time frame: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Fasting Glucose at Baseline
Time frame: Baseline (all participants)
Fasting glucose blood levels
Fasting lipids at Baseline
Time frame: Baseline (all participants)
Fasting lipid blood levels
Fasting hepatic function panel at Baseline: total protein
Time frame: Baseline (all participants)
Fasting levels of total protein in the blood
Fasting hepatic function panel at Baseline: albumin
Time frame: Baseline (all participants)
Fasting levels of albumin in the blood
Fasting hepatic function panel at Baseline: bilirubin
Time frame: Baseline (all participants)
Fasting levels of bilirubin in the blood
Fasting hepatic function panel at Baseline: liver enzyme
Time frame: Baseline (all participants)
Fasting levels of liver enzyme in the blood
Fasting Glucose at halfway point through first dietary phase
Time frame: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting glucose blood levels
Fasting lipids at halfway point through first dietary phase
Time frame: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting lipid blood levels
Fasting hepatic function at halfway point through first dietary phase: total protein
Time frame: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting levels of total protein in the blood
Fasting hepatic function at halfway point through first dietary phase: albumin
Time frame: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting levels of albumin in the blood
Fasting hepatic function at halfway point through first dietary phase: bilirubin
Time frame: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting levels of bilirubin in the blood
Fasting hepatic function at halfway point through first dietary phase: liver enzyme
Time frame: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting levels of liver enzyme in the blood
Fasting Glucose at end of first dietary phase
Time frame: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting glucose blood levels
Fasting lipids at end of first dietary phase
Time frame: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting lipid blood levels
Fasting hepatic function at end of first dietary phase: total protein
Time frame: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting levels of total protein in the blood
Fasting hepatic function at end of first dietary phase: albumin
Time frame: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting levels of albumin in the blood
Fasting hepatic function at end of first dietary phase: bilirubin
Time frame: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting levels of bilirubin in the blood
Fasting hepatic function at end of first dietary phase: liver enzyme
Time frame: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting levels of liver enzyme in the blood
Fasting Glucose at halfway point through second dietary phase
Time frame: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting glucose blood levels
Fasting lipids at halfway point through second dietary phase
Time frame: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting lipid blood levels
Fasting hepatic function at halfway point through second dietary phase: total protein
Time frame: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting levels of total protein in the blood
Fasting hepatic function at halfway point through second dietary phase: albumin
Time frame: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting levels of albumin in the blood
Fasting hepatic function at halfway point through second dietary phase: bilirubin
Time frame: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting levels of bilirubin in the blood
Fasting hepatic function at halfway point through second dietary phase: liver enzyme
Time frame: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting levels of liver enzyme in the blood
Fasting Glucose at end of second dietary phase
Time frame: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting glucose blood levels
Fasting lipids at end of second dietary phase
Time frame: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting lipids blood levels
Fasting hepatic function at end of second dietary phase: total protein
Time frame: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting levels of total protein in the blood
Fasting hepatic function at end of second dietary phase: albumin
Time frame: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting levels of albumin in the blood
Fasting hepatic function at end of second dietary phase: bilirubin
Time frame: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting levels of bilirubin in the blood
Fasting hepatic function at end of second dietary phase: liver enzyme
Time frame: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting levels of liver enzyme in the blood
Gamma-aminobutyric acid (GABA) at Baseline
Time frame: Baseline Scan 1 (all participants)
Gamma-aminobutyric acid (GABA) concentrations in the brain
Glutamate at Baseline
Time frame: Baseline Scan 1 (all participants)
Glutamate concentrations in the brain
Lactate at Baseline
Time frame: Baseline Scan 1 (all participants)
Lactate concentrations in the brain
Gamma-aminobutyric acid (GABA) at end of first dietary phase
Time frame: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Gamma-aminobutyric acid (GABA) concentrations in the brain
Glutamate at end of first dietary phase
Time frame: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Glutamate concentrations in the brain
Lactate at end of first dietary phase
Time frame: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Lactate concentrations in the brain
Gamma-aminobutyric acid (GABA) at end of second dietary phase
Time frame: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Gamma-aminobutyric acid (GABA) concentrations in the brain
Glutamate at end of second dietary phase
Time frame: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Glutamate concentrations in the brain
Lactate at end of second dietary phase
Time frame: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Lactate concentrations in the brain
8 secondary outcomes
Average total sleep time during Ketogenic vs Normal diet
Time frame: Wrist actigraphy will be collected throughout the 8-10wk ketogenic diet and normal diet study intervals
Average rest-activity rhythm interdaily stability during Ketogenic vs Normal diet
Time frame: Wrist actigraphy will be collected throughout the 8-10 wk ketogenic diet and normal diet study intervals.
Ecological momentary assessments (EMA) during the first dietary phase: Mood monitoring
Time frame: The first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Ecological momentary assessments (EMA) during the first dietary phase: Energy monitoring
Time frame: The first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Ecological momentary assessments (EMA) during the first dietary phase: Suicidality monitoring
Time frame: The first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Ecological momentary assessments (EMA) during the second dietary phase: Mood monitoring
Time frame: The second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Ecological momentary assessments (EMA) during the second dietary phase: Energy monitoring
Time frame: The second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Ecological momentary assessments (EMA) during the second dietary phase: Suicidality monitoring
Time frame: The second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Yes. Informed consent will be collected from study participants that allows for broad sharing of participants' de-identified data. Data transfer procedures will be in accordance with all Institutional Review Board guidelines and federal regulations including HIPAA (Health Insurance Portability and Accountability Act of 1996).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Phillips, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-ketogenic Diet, Ketogenic Diet and No diet in people with Bipolar Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill Morris-Tillman (412-383-8206, morristillmanje@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygen level-dependent (BOLD) signal at Scan 1 (time frame: Baseline Scan 1 (all participants)). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.