Bipolar Disorder INCT05705063
Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness
A study testing LCHF Ketogenic Diet in people with Bipolar Disorder I and Bipolar II Disorder, run by Stanford University at 1 site in United States.
Trial summary
To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with bipolar illness who also have metabolic abnormalities, overweight/obesity, and/or are currently taking psychotropic medications experiencing metabolic side effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Disorder I, Bipolar II Disorder, Bipolar I Disorder
- What is being tested?
- LCHF Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 75 years of age.
- Able to provide informed consent.
- Meet DSM V criteria for diagnosis with Bipolar Disorder (BPD), any subtype, for > 1 year and clinically stable (with no hospitalization for past 3 months)
- Participants may currently be on a stable and adequate dose of SSRI antidepressant therapy or other psychiatric medications. Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least 4 weeks prior to screening and if it is expected to remain stable. Participants may choose to not be on antidepressant therapy for the study duration, or to be switched from other classes to a medication from the SSRI class.
- currently taking SSRI or psychotropic medication and gained at least 5% weight since starting medication or have a BMI greater than or equal to 26 kg/m2 or presence of at least one metabolic abnormality (hypertriglyceridemia, insulin resistance, dyslipidemia, impaired glucose tolerance)
- In good general health, as ascertained by medical history.
Show all 10Show fewer
- If female, a status of non-childbearing potential or use of an acceptable form of birth control. The form of birth control will be documented at screening and baseline.
- willing to consent to all study procedures and attend follow-up appointments and motivated to follow dietary program.
- Sufficient control over their food intake to adhere to study diets.
- willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over 6-week trial
Who cannot join
- Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
- Female that is pregnant or breastfeeding.
- Female with a positive pregnancy test at participation.
- comorbidity of developmental delay or Cognitive impairment (as noted by previous diagnoses-including dementia).
- Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence, at screening or within six months prior to screening.
- History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
Show all 23Show fewer
- Current (or chronic) use of opiates.
- in a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary program.
- Considered at significant risk for suicide during the course of the study.
- any one who has been hospitalized or taken clozapine at doses above 550mg over the past 3 months
- Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
- Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
- Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
- inability to complete baseline measurements
- severe renal or hepatic insufficiency
- cardiovascular dysfunction, including diagnosis of:
- Congestive heart failure
- Angina
- Arrhythmias
- Cardiomyopathy
- Valvular heart disease
- History of cardiovascular disease or cardiac event.
- any other medical condition that may make either diet dangerous as determined by the study medical team (e.g. anorexia nervosa)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94704
Diane E Wakeham, PhD, 650-736-5243, wakeham@stanford.edu
Study Coordinator, 650-736-5243
About this study
Official title: Impact of A Low-Carbohydrate, High-Fat, Ketogenic Diet on Obesity, Metabolic Abnormalities, and Psychiatric Symptoms on Patients With Bipolar Disorder (BPD)
To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with bipolar illness who also have metabolic abnormalities, overweight/obesity, and/or are currently taking psychotropic medications experiencing metabolic side effects.
Read the detailed description
Adults with mental illness represent a high-risk, marginalized group in the current metabolic and obesity epidemic. Among US adults with severe mental illness, metabolic syndrome are highly prevalent conditions having severe consequences, with patients estimated to die on average 25 years earlier than the general population largely of premature cardiovascular disease. Many psychiatric medications, particularly neuroleptics and mood stabilizers, may, in addition, contribute to metabolic side effects and weight gain. Low-carbohydrate high-fat (LCHF) or ketogenic diets (KD) have been shown to reduce cardiovascular risk in those with insulin resistance. Recent findings support the idea that bipolar disorder may have roots of metabolic dysfunction: cerebral glucose hypometabolism, oxidative stress, as well as mitochondrial and neurotransmitter dysfunction which has downstream effects on synapse connections. A KD diet provides alternative fuel to the brain aside from glucose and is believed to contain beneficial neuroprotective effects, including stabilization of brain networks, reduction of inflammation and oxidative stress. The purpose of this study is to evaluate both the metabolic and psychiatric outcomes with a KD diet in this psychiatric population.
- Conditions
- Bipolar Disorder I, Bipolar II Disorder, Bipolar I Disorder, Bipolar Disorder, Bipolar Depression, Bipolar and Related Disorders
- Being tested
- LCHF Ketogenic Diet
- Medical subject headings
- Bipolar Disorder, Bipolar and Related Disorders, Obesity, Metabolic Syndrome, Weight Gain, Brain Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCHF Ketogenic DietOther
Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Patients | Experimental | Patients follow ketogenic diet for 16 weeks, with monitoring of physical and psychological health and coaching support Receives: Other: LCHF Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight from Baseline
Weight recorded weekly during study
Measured: Baseline, 6 weeks
Change in Waist Circumference from Baseline
Waist circumference recorded at each visit during study
Measured: Baseline, 6 weeks
Change in Heart Rate from Baseline
Heart rate recorded at each visit during study
Measured: Baseline, 6 weeks
Change in Blood Pressure from Baseline
Blood pressure recorded weekly during study
Measured: Baseline, 6 weeks
Change in Visceral Fat Mass from Baseline
Kg visceral fat in body composition (SECA or Inbody) recorded 2-3 times during study
Measured: Baseline, 6 weeks
Change in Body Fat Mass from Baseline
Kg body fat in body composition (SECA or Inbody) recorded 2-3 times during study
Measured: Baseline, 6 weeks
Change in Hemoglobin A1c from Baseline
Blood measurement of Hemoglobin A1c recorded at baseline and study end
Measured: Baseline, 6 weeks
Change in Insulin Resistance Measure (HOMA-IR) from Baseline
HOMA-IR calculated from blood measurements recorded at baseline and study end
Measured: Baseline, 6 weeks
Change in Inflammatory Marker (hs-CRP) from Baseline
Blood measurement of hs-CRP recorded at baseline and study end
Measured: Baseline, 6 weeks
Change in Lipid Profile (TG) from Baseline
Blood levels of Lipid Triglycerides (TG) recorded at baseline and study end
Measured: Baseline, 6 weeks
Change in Lipid Profile small LDL from Baseline
Blood levels of small, low density lipoprotein cholesterol (LDL-C) recorded at baseline and study end
Measured: Baseline, 6 weeks
Change in Lipid Profile HDL from Baseline
Blood levels of high density lipoprotein cholesterol (HDL-C) recorded at baseline and study end
Measured: Baseline, 6 weeks
Secondary outcomes (8)
Change in Clinical Mood Monitoring from Baseline
Change in Clinical Mood Monitoring Psychiatric Index from Baseline
Measured: Baseline, 6 weeks
Change in Clinical Global Impression from Baseline
Change in Clinical Global Impression (CGI) Psychiatric Index from Baseline; 1-7 scale. (1= not at all ill, 7= among the most extremely ill patients)
Measured: Baseline, 6 weeks
Change Generalized Anxiety Disorder from Baseline
Change in General Anxiety Disorder (GAD-7) scale from Baseline. 0-15+ scale. (0= no anxiety, 15+= severe anxiety)
Measured: Baseline, 6 weeks
Change in Depression from Baseline
Change in Depression on Patient Health Questionnaire (PHQ-9) scale from Baseline; Score range 0-27 (0= no depression, 27= severe depression)
Measured: Baseline, 6 weeks
Change in Global Assessment of Functioning from Baseline
Change in Global Assessment of Functioning (GAF) scale from baseline; 1-100 scale (1= persistent danger of hurting self or others, 100= superior functioning)
Measured: Baseline, 6 weeks
Change in Quality of Life from Baseline
Change in Manchester Quality of Life (MANSA) scale from baseline; Range 12-84 (each of 12 outcomes rated from 1= could not be worse to 7= could not be better; <4= dissatisfied with QoL, >4= satisfied with QoL)
Measured: Baseline, 6 weeks
Change in Quality of Sleep from Baseline
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline; 0-21 scale (<5=good sleeper; 5+= meaningfully disturbed sleep or poor sleeper)
Measured: Baseline, 6 weeks
Change in Eating Behavior from Baseline
Change in Binge Eating Scale (BES) from Baseline; 0-46 scale (<17 minimal binge eating problems, >27 severe binge eating problems)
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start30 Jan 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder IStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shebani Sethi, Stanford University
- Investigators
- Shebani Sethi, MD, Principal investigator, Stanford University Dept Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705063
- Sponsor's protocol ID
- 68493
- Status last verified
- Jan 2023
- First submitted
- 21 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carmen M, Safer DL, Saslow LR, Kalayjian T, Mason AE, Westman EC, Sethi S. Treating binge eating and food addiction symptoms with low-carbohydrate Ketogenic diets: a case series. J Eat Disord. 2020 Jan 29;8:2. doi: 10.1186/s40337-020-0278-7. eCollection 2020.
PubMed 32010444Norwitz NG, Sethi S, Palmer CM. Ketogenic diet as a metabolic treatment for mental illness. Curr Opin Endocrinol Diabetes Obes. 2020 Oct;27(5):269-274. doi: 10.1097/MED.0000000000000564.
PubMed 32773571Brietzke E, Mansur RB, Subramaniapillai M, Balanza-Martinez V, Vinberg M, Gonzalez-Pinto A, Rosenblat JD, Ho R, McIntyre RS. Ketogenic diet as a metabolic therapy for mood disorders: Evidence and developments. Neurosci Biobehav Rev. 2018 Nov;94:11-16. doi: 10.1016/j.neubiorev.2018.07.020. Epub 2018 Jul 31.
PubMed 30075165Unwin J, Delon C, Giaever H, Kennedy C, Painschab M, Sandin F, Poulsen CS, Wiss DA. Low carbohydrate and psychoeducational programs show promise for the treatment of ultra-processed food addiction. Front Psychiatry. 2022 Sep 28;13:1005523. doi: 10.3389/fpsyt.2022.1005523. eCollection 2022.
PubMed 36245868Danan A, Westman EC, Saslow LR, Ede G. The Ketogenic Diet for Refractory Mental Illness: A Retrospective Analysis of 31 Inpatients. Front Psychiatry. 2022 Jul 6;13:951376. doi: 10.3389/fpsyt.2022.951376. eCollection 2022.
PubMed 35873236Sethi S, Ford JM. The Role of Ketogenic Metabolic Therapy on the Brain in Serious Mental Illness: A Review. J Psychiatr Brain Sci. 2022;7(5):e220009. doi: 10.20900/jpbs.20220009. Epub 2022 Oct 31.
PubMed 36483840Imdad K, Abualait T, Kanwal A, AlGhannam ZT, Bashir S, Farrukh A, Khattak SH, Albaradie R, Bashir S. The Metabolic Role of Ketogenic Diets in Treating Epilepsy. Nutrients. 2022 Nov 29;14(23):5074. doi: 10.3390/nu14235074.
PubMed 36501104Sethi S, Sinha A, Gearhardt AN. Low carbohydrate ketogenic therapy as a metabolic treatment for binge eating and ultraprocessed food addiction. Curr Opin Endocrinol Diabetes Obes. 2020 Oct;27(5):275-282. doi: 10.1097/MED.0000000000000571.
PubMed 32773576
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of A Low-Carbohydrate, High-Fat, Ketogenic Diet on Obesity, Metabolic Abnormalities, and Psychiatric Symptoms on Patients With Bipolar Disorder (BPD)
- ClinicalTrials.gov ID
- NCT05705063
- Acronym / sponsor ID
- 68493
- Conditions
- Bipolar Disorder I, Bipolar II Disorder, Bipolar I Disorder, Bipolar Disorder, Bipolar Depression, Bipolar and Related Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 30 Jan 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.
To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with bipolar illness who also have metabolic abnormalities, overweight/obesity, and/or are currently taking psychotropic medications experiencing metabolic side effects.
Detailed description
Adults with mental illness represent a high-risk, marginalized group in the current metabolic and obesity epidemic. Among US adults with severe mental illness, metabolic syndrome are highly prevalent conditions having severe consequences, with patients estimated to die on average 25 years earlier than the general population largely of premature cardiovascular disease. Many psychiatric medications, particularly neuroleptics and mood stabilizers, may, in addition, contribute to metabolic side effects and weight gain. Low-carbohydrate high-fat (LCHF) or ketogenic diets (KD) have been shown to reduce cardiovascular risk in those with insulin resistance. Recent findings support the idea that bipolar disorder may have roots of metabolic dysfunction: cerebral glucose hypometabolism, oxidative stress, as well as mitochondrial and neurotransmitter dysfunction which has downstream effects on synapse connections. A KD diet provides alternative fuel to the brain aside from glucose and is believed to contain beneficial neuroprotective effects, including stabilization of brain networks, reduction of inflammation and oxidative stress. The purpose of this study is to evaluate both the metabolic and psychiatric outcomes with a KD diet in this psychiatric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Bipolar Patients | Experimental | Other: LCHF Ketogenic DietPatients follow ketogenic diet for 16 weeks, with monitoring of physical and psychological health and coaching support |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, 18 to 75 years of age.
- Able to provide informed consent.
- Meet DSM V criteria for diagnosis with Bipolar Disorder (BPD), any subtype, for > 1 year and clinically stable (with no hospitalization for past 3 months)
- Participants may currently be on a stable and adequate dose of SSRI antidepressant therapy or other psychiatric medications. Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least 4 weeks prior to screening and if it is expected to remain stable. Participants may choose to not be on antidepressant therapy for the study duration, or to be switched from other classes to a medication from the SSRI class.
- currently taking SSRI or psychotropic medication and gained at least 5% weight since starting medication or have a BMI greater than or equal to 26 kg/m2 or presence of at least one metabolic abnormality (hypertriglyceridemia, insulin resistance, dyslipidemia, impaired glucose tolerance)
Key exclusion criteria (23 listed)
- Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
- Female that is pregnant or breastfeeding.
- Female with a positive pregnancy test at participation.
- comorbidity of developmental delay or Cognitive impairment (as noted by previous diagnoses-including dementia).
- Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence, at screening or within six months prior to screening.
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 |
|---|---|---|
| LCHF Ketogenic DietLow Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 6 weeks | Other | Bipolar Patients |
Primary outcome
Change in Weight from Baseline
Time frame: Baseline, 6 weeks
Weight recorded weekly during study
Change in Waist Circumference from Baseline
Time frame: Baseline, 6 weeks
Waist circumference recorded at each visit during study
Change in Heart Rate from Baseline
Time frame: Baseline, 6 weeks
Heart rate recorded at each visit during study
Change in Blood Pressure from Baseline
Time frame: Baseline, 6 weeks
Blood pressure recorded weekly during study
Change in Visceral Fat Mass from Baseline
Time frame: Baseline, 6 weeks
Kg visceral fat in body composition (SECA or Inbody) recorded 2-3 times during study
Change in Body Fat Mass from Baseline
Time frame: Baseline, 6 weeks
Kg body fat in body composition (SECA or Inbody) recorded 2-3 times during study
Change in Hemoglobin A1c from Baseline
Time frame: Baseline, 6 weeks
Blood measurement of Hemoglobin A1c recorded at baseline and study end
Change in Insulin Resistance Measure (HOMA-IR) from Baseline
Time frame: Baseline, 6 weeks
HOMA-IR calculated from blood measurements recorded at baseline and study end
Change in Inflammatory Marker (hs-CRP) from Baseline
Time frame: Baseline, 6 weeks
Blood measurement of hs-CRP recorded at baseline and study end
Change in Lipid Profile (TG) from Baseline
Time frame: Baseline, 6 weeks
Blood levels of Lipid Triglycerides (TG) recorded at baseline and study end
Change in Lipid Profile small LDL from Baseline
Time frame: Baseline, 6 weeks
Blood levels of small, low density lipoprotein cholesterol (LDL-C) recorded at baseline and study end
Change in Lipid Profile HDL from Baseline
Time frame: Baseline, 6 weeks
Blood levels of high density lipoprotein cholesterol (HDL-C) recorded at baseline and study end
8 secondary outcomes
Change in Clinical Mood Monitoring from Baseline
Time frame: Baseline, 6 weeks
Change in Clinical Global Impression from Baseline
Time frame: Baseline, 6 weeks
Change Generalized Anxiety Disorder from Baseline
Time frame: Baseline, 6 weeks
Change in Depression from Baseline
Time frame: Baseline, 6 weeks
Change in Global Assessment of Functioning from Baseline
Time frame: Baseline, 6 weeks
Change in Quality of Life from Baseline
Time frame: Baseline, 6 weeks
Change in Quality of Sleep from Baseline
Time frame: Baseline, 6 weeks
Change in Eating Behavior from Baseline
Time frame: Baseline, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Background: PubMed 32010444Carmen M, Safer DL, Saslow LR, Kalayjian T, Mason AE, Westman EC, Sethi S. Treating binge eating and food addiction symptoms with low-carbohydrate Ketogenic diets: a case series. J Eat Disord. 2020 Jan 29;8:2. doi: 10.1186/s40337-020-0278-7. eCollection 2020.
- Background: PubMed 32773571Norwitz NG, Sethi S, Palmer CM. Ketogenic diet as a metabolic treatment for mental illness. Curr Opin Endocrinol Diabetes Obes. 2020 Oct;27(5):269-274. doi: 10.1097/MED.0000000000000564.
- Background: PubMed 30075165Brietzke E, Mansur RB, Subramaniapillai M, Balanza-Martinez V, Vinberg M, Gonzalez-Pinto A, Rosenblat JD, Ho R, McIntyre RS. Ketogenic diet as a metabolic therapy for mood disorders: Evidence and developments. Neurosci Biobehav Rev. 2018 Nov;94:11-16. doi: 10.1016/j.neubiorev.2018.07.020. Epub 2018 Jul 31.
- Background: PubMed 36245868Unwin J, Delon C, Giaever H, Kennedy C, Painschab M, Sandin F, Poulsen CS, Wiss DA. Low carbohydrate and psychoeducational programs show promise for the treatment of ultra-processed food addiction. Front Psychiatry. 2022 Sep 28;13:1005523. doi: 10.3389/fpsyt.2022.1005523. eCollection 2022.
- Background: PubMed 35873236Danan A, Westman EC, Saslow LR, Ede G. The Ketogenic Diet for Refractory Mental Illness: A Retrospective Analysis of 31 Inpatients. Front Psychiatry. 2022 Jul 6;13:951376. doi: 10.3389/fpsyt.2022.951376. eCollection 2022.
- Background: PubMed 36483840Sethi S, Ford JM. The Role of Ketogenic Metabolic Therapy on the Brain in Serious Mental Illness: A Review. J Psychiatr Brain Sci. 2022;7(5):e220009. doi: 10.20900/jpbs.20220009. Epub 2022 Oct 31.
- Background: PubMed 36501104Imdad K, Abualait T, Kanwal A, AlGhannam ZT, Bashir S, Farrukh A, Khattak SH, Albaradie R, Bashir S. The Metabolic Role of Ketogenic Diets in Treating Epilepsy. Nutrients. 2022 Nov 29;14(23):5074. doi: 10.3390/nu14235074.
- Results publication: PubMed 32773576Sethi S, Sinha A, Gearhardt AN. Low carbohydrate ketogenic therapy as a metabolic treatment for binge eating and ultraprocessed food addiction. Curr Opin Endocrinol Diabetes Obes. 2020 Oct;27(5):275-282. doi: 10.1097/MED.0000000000000571.
- Ketogenic diet as a metabolic therapy for bipolar disorder: Clinical developmentsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Shebani Sethi, MD principal investigator
Stanford University Dept Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCHF Ketogenic Diet in people with Bipolar Disorder I and Bipolar II Disorder, run by Stanford University 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 10 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 30 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diane E Wakeham, PhD (650-736-5243, wakeham@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight from Baseline (time frame: Baseline, 6 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05705063, which also lists 8 linked publications.
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 30 Jan 2023.