DepressionKINDNCT06080932
Ketogenic Intervention in Depression
A study testing Ketogenic Diet, NIH Toolbox and gradCPT in people with Depression and Ketosis, run by Ohio State University at 1 site in United States.
Trial summary
The goal of this study is to examine whether a well-formulated ketogenic diet (KD) can be implemented into a university counseling treatment program for major depression and to test whether such a program has any benefit on mental and metabolic health. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Ketosis
- What is being tested?
- Ketogenic Diet, NIH Toolbox and gradCPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 21 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- OSU students (age 18-30 years at the time of enrollment) with confirmed major depressive disorder as determined by SCID-5 diagnosis at baseline testing.
- Currently engaged in counseling treatment for depression at CCS
- Available for a 12-week period and indicate willingness and ability to eat KD foods as prescribed
Who cannot join
- Disordered eating, as evidenced by meeting criteria for Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Other Specified Eating Disorder, Unspecified Eating Disorder, or Avoidant Restrictive Eating Disorder during the SCID-5 interview at baseline testing.
- Substantial imminent risk of suicide as assessed during the SCID-5 interview.
- Body mass index (BMI) < 20 kg/m2
- Habitual consumption of a structured low-carbohydrate diet in the last 6-months
- Gastrointestinal disorders or allergies that would prevent adherence to prescribed diets
- Alcohol consumption in excess of 3 drinks/daily or 14 drinks/weekly
Show all 11Show fewer
- Diagnosed diabetes, liver, kidney, or other metabolic or endocrine dysfunction, or use of diabetic medications other than metformin
- Inability to access or prepare appropriate KD foods/meals
- Pregnant, lactating, or planning on becoming pregnant during the study
- Unwilling to perform finger-stick blood testing or continuous glucose/ketone monitoring
- The CCBBI screening form (https://redcap.osumc.edu/redcap/surveys/?s=N3XJ4WC7T9) will be used to assess MRI eligibility. Endorsement of items that contraindicate MRI will serve as exclusion criteria (pacemaker, stint, claustrophobia, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to examine whether a well-formulated ketogenic diet (KD) can be implemented into a university counseling treatment program for major depression and to test whether such a program has any benefit on mental and metabolic health.
Read the detailed description
Major depression is a burgeoning problem that affects over five percent of adults worldwide and is rapidly increasing in the United States. From the second quarter of 2019 to June of 2020, the prevalence of symptoms of depression spiked from 6.5 to 24.3% , which was largely attributed to the COVID-19 pandemic. Major depression and suicidal ideation have increased markedly in young adults, particularly within college campuses. In 2020, counselors at the Ohio State University (OSU) experienced a surge in the number of students with various mental health issues with anxiety and depressive disorders being the most common. The escalating prevalence of depression bubbling under the surface of the ongoing COVID-19 pandemic represents a unique challenge that requires new and creative solutions.
Recently, a KD was administered to adults who had been admitted to a psychiatric hospital and were suffering from various mental disorders. The dietary intervention lasted between 16 and 248 days and showed significant improvements in depression and psychotic symptoms. Ketogenic diet interventions (and ingestion of ketone esters) have also been associated with more stable brain networks, assess with functional Magnetic Resonance Imaging (fMRI). Additionally, a novel but as yet under-appreciated effect of nutritional ketosis is to induce a broad-spectrum reduction in inflammation in metabolically-impaired individuals. Elevations in a range of inflammation biomarkers has been associated with severity of depression.
Although KDs have been proposed as a treatment option for mental health disorders, including schizophrenia and depression, few human clinical trials have tested the efficacy of this eating pattern specifically in a population of adults with major depression. In patients with type 2 diabetes (n=262) prescribed a KD using a novel virtual care model (Virta Health), we observed significant improvements in depressive symptoms after 10-weeks, which were directly correlated with the degree of carbohydrate restriction and nutritional ketosis as assessed by blood concentrations of ketones.
- Conditions
- Depression, Ketosis
- Being tested
- Ketogenic Diet, NIH Toolbox, gradCPT, Resting-state fMRI, Task-fMRI
- Medical subject headings
- Depression, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietOther
The diet intervention will start after all baseline testing is complete
NIH ToolboxOther
IPAD-based assessments that examines cognitive function
gradCPTOther
The gradCPT contains grayscale photographs of mountain scenes and city scenes. Scene images gradually transition from one image to the next
Resting-state fMRIOther
Whole brain echo-planar imaging (EPI) volumes sensitive to the BOLD signal will be acquired. Images will be re-aligned, un-warped, and normalized. Confounding effects of white matter, CSF signal, and head motion will be regressed from the functional time series, followed by bandpass filtering, linear detrending and smoothing, and whole brain resting state networks will be identified (e.g., default mode network, salience network, etc).
Task-fMRIOther
During whole brain EPI data acquisition, participants will be presented with words and pictures and asked to make judgements about the stimuli, such as indicating whether a particular stimulus (e.g., face-name association, word, number, or letter) has been previously presented, if a presented stimulus is a city or mountain scene, the direction an arrow is pointing (left or right), if a pair of stimuli match (e.g., faces with neutral or emotional expressions; word with a face). Behavioral responses will be recorded with an MRI compatible button box.
CGM/CKMOther
Continuous Ketone/Glucose Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at ~2- week intervals during the study. The sensor will be removed at the end of the final test day.
Blood DrawBiological
Blood samples will be collected according to the schedule in Figure 1
Sleep MonitoringOther
Sleep will be assessed by ring-based acceleration with cloud technology (Oura Ring). This monitor is less burdensome than other sleep monitoring technologies and less likely to interfere with normal sleep and activity demands. Worn daily throughout intervention
Ketone/Glucose MonitoringBiological
KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
Body CompositionOther
DEXA Scanning will be done pre-, mid-, and post- intervention.
PHQ-9Behavioural
It is a self-assessment tool used to screen and assess the severity of depression in individuals. The PHQ-9 consists of nine questions based on the nine criteria for diagnosing major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
WHO-5Behavioural
The WHO-5, also known as the World Health Organization-Five Well-Being Index, is a self-assessment tool used to measure subjective well-being and mental health. It was developed by the World Health Organization (WHO) as a brief and reliable instrument to evaluate well-being in clinical and research settings.
SKIDBehavioural
The SKID refers to the Structured Clinical Interview for DSM Disorders (SCID). It is a widely used diagnostic tool in the field of psychiatry and clinical psychology. The SCID is a semi-structured interview designed to assess and diagnose various mental disorders according to the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is published by the American Psychiatric Association.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | The KD will follow general principles as we have described with the aim to achieve blood ketones >0.5 mM, which will require most participants to consume <50 g/day carbohydrate and ~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods. Receives: Other: Ketogenic Diet; Other: NIH Toolbox; Other: gradCPT; Other: Resting-state fMRI; Other: Task-fMRI; Other: CGM/CKM; Biological: Blood Draw; Other: Sleep Monitoring; Biological: Ketone/Glucose Monitoring; Other: Body Composition; Behavioral: PHQ-9; Behavioral: WHO-5; Behavioral: SKID |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO-5 Questionnaire
The WHO-5 (World Health Organization-Five Well-Being Index) is a self-assessment questionnaire used to measure subjective well-being and mental health. It was developed by the World Health Organization (WHO) and consists of five statements related to positive mood, vitality, and general interest in life. The five statements in the WHO-5 questionnaire are as follows:
I have felt cheerful and in good spirits. I have felt calm and relaxed. I have felt active and vigorous. I woke up feeling fresh and rested. My daily life has been filled with things that interest me. Respondents are asked to rate each statement based on how they have felt over the past two weeks, using a six-point Likert scale ranging from "at no time" to "all of the time." The scores for each item are summed, resulting in a total score ranging from 0 to 25. Higher scores indicate better well-being
Measured: Up to ~ 12 weeks
The Hamilton Depression Scale
Hamilton Depression Scale consists of 17 items that cover various symptoms of depression, including depressed mood, guilt, suicidal thoughts, insomnia, agitation, weight loss, and somatic symptoms. Each item is rated on a scale from 0 to 4 or 0 to 2, depending on the item, with higher scores indicating more severe symptoms.
The scale is typically administered by a trained healthcare professional who interviews the individual and rates their symptoms based on their observations and the individual's self-report. The rater assesses the severity of each symptom and determines the appropriate score for each item.
The total score on the Hamilton Depression Scale can range from 0 to 52, with higher scores indicating greater severity of depression. However, it is important to note that the interpretation of the total score requires clinical judgment and consideration of the individual's overall presentation and context.
Measured: Up to ~ 12 Weeks
Finger Stick BHB
changes in fasting ketone levels.
Measured: Up to ~ 12 Weeks
Finger Stick Glucose
changes in fasting glucose levels.
Measured: Up to ~ 12 Weeks
Secondary outcomes (10)
PHQ-9
The Patient Health Questionnaire-9 used bi-weekly to asses changes in degree of depression (intensity and severity).
Each item in the PHQ-9 is rated on a scale from 0 to 3, reflecting the frequency of the symptoms over the past two weeks. The response options are "not at all" (0), "several days" (1), "more than half the days" (2), and "nearly every day" (3). The scores for each item are summed to obtain a total score ranging from 0 to 27.
The interpretation of PHQ-9 scores is as follows:
0-4: None to minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20 and above: Severe depression
Measured: Up to ~ 12 Weeks
CGM/CKM
changes in daily glucose and ketone levels.
Measured: Up to ~ 12 Weeks
Metabolic Panel
Changes in metabolic blood panel will be assessed at in lab visits (eg. Baseline, Week 6, and Week 12)
Measured: Up to ~ 12 Weeks
Blood Pressure
Changes in both Systolic and Diastolic blood pressure will be measured at each lab visit (eg. Baseline, Week 6, and Week 12).
Recording: The systolic and diastolic pressures are recorded in millimeters of mercury (mmHg). For example, a reading of "120/80 mmHg" indicates a systolic pressure of 120 mmHg and a diastolic pressure of 80 mmHg.
Measured: Up to ~ 12 Weeks
Cognitive Testing
The NIH Toolbox includes a comprehensive set of measures across various domains, including:
Cognition: executive function, attention, memory, language, processing speed, and working memory. These measures help evaluate cognitive abilities and identify potential cognitive impairments.
Emotion: emotional well-being, social functioning, and psychological distress. It provides tools to assess symptoms of depression, anxiety, and positive affect, as well as social functioning and quality of life.
Motor: motor function, dexterity, strength, coordination, and balance. These assessments are designed to evaluate both fine and gross motor skills and detect any motor impairments or changes over time.
Sensation: auditory, visual, and somatosensory abilities. These measures help evaluate sensory perception, discrimination, and thresholds.
Measured: Up to ~ 12 Weeks
Task-fMRI
During whole brain EPI data acquisition, participants will be presented with words and pictures and asked to make judgements about the stimuli, such as indicating whether a particular stimulus (e.g., face-name association, word, number, or letter) has been previously presented, if a presented stimulus is a city or mountain scene, the direction an arrow is pointing (left or right), if a pair of stimuli match (e.g., faces with neutral or emotional expressions; word with a face). Behavioral responses will be recorded with an MRI compatible button box.
Measured: Up to ~ 12 Weeks
Resting State fMRI
Changes in cortical thickness, brain volume, and functional connectivity for pre- intervention and post intervention testing days.
Whole brain echo-planar imaging (EPI) volumes sensitive to the BOLD signal will be acquired. Images will be re-aligned, un-warped, and normalized. Confounding effects of white matter, CSF signal, and head motion will be regressed from the functional time series, followed by bandpass filtering, linear detrending and smoothing, and whole brain resting state networks will be identified (e.g., default mode network, salience network, etc).
Measured: Up to ~ 12 Weeks
Lean Body Mass (kg)
Changes in lean body mass.
Measured: Up to ~ 12 Weeks
Changes in BMI
Changes in body mass index.
Measured: Up to ~ 12 Weeks
Changes in total body weight ( kg)
Changes in total body weight.
Measured: Up to ~ 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start20 Feb 2023
- Primary completion1 Jun 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080932
- Sponsor's protocol ID
- 2022H0271
- Acronym
- KIND
- Status last verified
- May 2025
- First submitted
- 1 Jun 2023
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Intervention in Depression
- ClinicalTrials.gov ID
- NCT06080932
- Acronym / sponsor ID
- KIND / 2022H0271
- Conditions
- Depression, Ketosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 12 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 goal of this study is to examine whether a well-formulated ketogenic diet (KD) can be implemented into a university counseling treatment program for major depression and to test whether such a program has any benefit on mental and metabolic health.
Detailed description
Major depression is a burgeoning problem that affects over five percent of adults worldwide and is rapidly increasing in the United States. From the second quarter of 2019 to June of 2020, the prevalence of symptoms of depression spiked from 6.5 to 24.3% , which was largely attributed to the COVID-19 pandemic. Major depression and suicidal ideation have increased markedly in young adults, particularly within college campuses. In 2020, counselors at the Ohio State University (OSU) experienced a surge in the number of students with various mental health issues with anxiety and depressive disorders being the most common. The escalating prevalence of depression bubbling under the surface of the ongoing COVID-19 pandemic represents a unique challenge that requires new and creative solutions.
Recently, a KD was administered to adults who had been admitted to a psychiatric hospital and were suffering from various mental disorders. The dietary intervention lasted between 16 and 248 days and showed significant improvements in depression and psychotic symptoms. Ketogenic diet interventions (and ingestion of ketone esters) have also been associated with more stable brain networks, assess with functional Magnetic Resonance Imaging (fMRI). Additionally, a novel but as yet under-appreciated effect of nutritional ketosis is to induce a broad-spectrum reduction in inflammation in metabolically-impaired individuals. Elevations in a range of inflammation biomarkers has been associated with severity of depression.
Although KDs have been proposed as a treatment option for mental health disorders, including schizophrenia and depression, few human clinical trials have tested the efficacy of this eating pattern specifically in a population of adults with major depression. In patients with type 2 diabetes (n=262) prescribed a KD using a novel virtual care model (Virta Health), we observed significant improvements in depressive symptoms after 10-weeks, which were directly correlated with the degree of carbohydrate restriction and nutritional ketosis as assessed by blood concentrations of ketones.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Experimental | Other: Ketogenic Diet, Other: NIH Toolbox, Other: gradCPT, Other: Resting-state fMRI, Other: Task-fMRI, Other: CGM/CKM, Biological: Blood Draw, Other: Sleep Monitoring, Biological: Ketone/Glucose Monitoring, Other: Body Composition, Behavioral: PHQ-9, Behavioral: WHO-5, Behavioral: SKIDThe KD will follow general principles as we have described with the aim to achieve blood ketones >0.5 mM, which will require most participants to consume <50 g/day carbohydrate and ~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- OSU students (age 18-30 years at the time of enrollment) with confirmed major depressive disorder as determined by SCID-5 diagnosis at baseline testing.
- Currently engaged in counseling treatment for depression at CCS
- Available for a 12-week period and indicate willingness and ability to eat KD foods as prescribed
Key exclusion criteria (11 listed)
- Disordered eating, as evidenced by meeting criteria for Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Other Specified Eating Disorder, Unspecified Eating Disorder, or Avoidant Restrictive Eating Disorder during the SCID-5 interview at baseline testing.
- Substantial imminent risk of suicide as assessed during the SCID-5 interview.
- Body mass index (BMI) < 20 kg/m2
- Habitual consumption of a structured low-carbohydrate diet in the last 6-months
- Gastrointestinal disorders or allergies that would prevent adherence to prescribed diets
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 |
|---|---|---|
| Ketogenic DietThe diet intervention will start after all baseline testing is complete | Other | Ketogenic Diet |
| NIH ToolboxIPAD-based assessments that examines cognitive function | Other | Ketogenic Diet |
| gradCPTThe gradCPT contains grayscale photographs of mountain scenes and city scenes. Scene images gradually transition from one image to the next | Other | Ketogenic Diet |
| Resting-state fMRIWhole brain echo-planar imaging (EPI) volumes sensitive to the BOLD signal will be acquired. Images will be re-aligned, un-warped, and normalized. Confounding effects of white matter, CSF signal, and head motion will be regressed from the functional time series, followed by bandpass filtering, linear detrending and smoothing, and whole brain resting state networks will be identified (e.g., default mode network, salience network, etc). | Other | Ketogenic Diet |
| Task-fMRIDuring whole brain EPI data acquisition, participants will be presented with words and pictures and asked to make judgements about the stimuli, such as indicating whether a particular stimulus (e.g., face-name association, word, number, or letter) has been previously presented, if a presented stimulus is a city or mountain scene, the direction an arrow is pointing (left or right), if a pair of stimuli match (e.g., faces with neutral or emotional expressions; word with a face). Behavioral responses will be recorded with an MRI compatible button box. | Other | Ketogenic Diet |
| CGM/CKMContinuous Ketone/Glucose Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at ~2- week intervals during the study. The sensor will be removed at the end of the final test day. | Other | Ketogenic Diet |
| Blood DrawBlood samples will be collected according to the schedule in Figure 1 | Biological | Ketogenic Diet |
| Sleep MonitoringSleep will be assessed by ring-based acceleration with cloud technology (Oura Ring). This monitor is less burdensome than other sleep monitoring technologies and less likely to interfere with normal sleep and activity demands. Worn daily throughout intervention | Other | Ketogenic Diet |
| Ketone/Glucose MonitoringKetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence. | Biological | Ketogenic Diet |
| Body CompositionDEXA Scanning will be done pre-, mid-, and post- intervention. | Other | Ketogenic Diet |
| PHQ-9It is a self-assessment tool used to screen and assess the severity of depression in individuals. The PHQ-9 consists of nine questions based on the nine criteria for diagnosing major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). | Behavioural | Ketogenic Diet |
| WHO-5The WHO-5, also known as the World Health Organization-Five Well-Being Index, is a self-assessment tool used to measure subjective well-being and mental health. It was developed by the World Health Organization (WHO) as a brief and reliable instrument to evaluate well-being in clinical and research settings. | Behavioural | Ketogenic Diet |
| SKIDThe SKID refers to the Structured Clinical Interview for DSM Disorders (SCID). It is a widely used diagnostic tool in the field of psychiatry and clinical psychology. The SCID is a semi-structured interview designed to assess and diagnose various mental disorders according to the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is published by the American Psychiatric Association. | Behavioural | Ketogenic Diet |
Primary outcome
WHO-5 Questionnaire
Time frame: Up to ~ 12 weeks
The WHO-5 (World Health Organization-Five Well-Being Index) is a self-assessment questionnaire used to measure subjective well-being and mental health. It was developed by the World Health Organization (WHO) and consists of five statements related to positive mood, vitality, and general interest in life. The five statements in the WHO-5 questionnaire are as follows: I have felt cheerful and in good spirits. I have felt calm and relaxed. I have felt active and vigorous. I woke up feeling fresh and rested. My daily life has been filled with things that interest me. Respondents are asked to rate each statement based on how they have felt over the past two weeks, using a six-point Likert scale ranging from "at no time" to "all of the time." The scores for each item are summed, resulting in a total score ranging from 0 to 25. Higher scores indicate better well-being
The Hamilton Depression Scale
Time frame: Up to ~ 12 Weeks
Hamilton Depression Scale consists of 17 items that cover various symptoms of depression, including depressed mood, guilt, suicidal thoughts, insomnia, agitation, weight loss, and somatic symptoms. Each item is rated on a scale from 0 to 4 or 0 to 2, depending on the item, with higher scores indicating more severe symptoms. The scale is typically administered by a trained healthcare professional who interviews the individual and rates their symptoms based on their observations and the individual's self-report. The rater assesses the severity of each symptom and determines the appropriate score for each item. The total score on the Hamilton Depression Scale can range from 0 to 52, with higher scores indicating greater severity of depression. However, it is important to note that the interpretation of the total score requires clinical judgment and consideration of the individual's overall presentation and context.
Finger Stick BHB
Time frame: Up to ~ 12 Weeks
changes in fasting ketone levels.
Finger Stick Glucose
Time frame: Up to ~ 12 Weeks
changes in fasting glucose levels.
10 secondary outcomes
PHQ-9
Time frame: Up to ~ 12 Weeks
CGM/CKM
Time frame: Up to ~ 12 Weeks
Metabolic Panel
Time frame: Up to ~ 12 Weeks
Blood Pressure
Time frame: Up to ~ 12 Weeks
Cognitive Testing
Time frame: Up to ~ 12 Weeks
Task-fMRI
Time frame: Up to ~ 12 Weeks
Resting State fMRI
Time frame: Up to ~ 12 Weeks
Lean Body Mass (kg)
Time frame: Up to ~ 12 Weeks
Changes in BMI
Time frame: Up to ~ 12 Weeks
Changes in total body weight ( kg)
Time frame: Up to ~ 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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Survivorship
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet, NIH Toolbox and gradCPT in people with Depression and Ketosis, run by Ohio State 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 29 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHO-5 Questionnaire (time frame: Up to ~ 12 weeks). The study lists 4 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 29 May 2025.