DepressionPhase 2NCT06263660
Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression
A Phase 2 study testing Keto-like supplement in people with Depression, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Keto-like supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2024to Dec 2027
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the Diagnostic and statistical manual - 5 (DSM-5) diagnostic criteria for MDD without psychotic features (past or present), as confirmed by the M.I.N.I v7.0
- PHQ-9 score of ≥10
- C-Reactive Protein (CRP) value > 1
- Age 18-65
- Consent ability and written consent
- Body Mass Index (BMI) between 19 and 38 kg/m2
Show all 10Show fewer
- Medically stable based on clinical laboratory tests, medical history and vital signs
- No intention to become pregnant during the study
- A woman of childbearing potential must have a negative serum pregnancy test at screening
- Consent that possible random finding is reported (e.g. brain abnormality during imaging)
Who cannot join
- Has a current or recent history of clinically significant suicidality
- Has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 12 months before screening
- Has positive test result(s) for alcohol or drugs of abuse (including methadone, opiates, cocaine, cannabinoids, amphetamine/methamphetamine and ecstasy)
- Has a current diagnosis of a psychotic disorder (e.g. schizophrenia, bipolar disorder), an eating disorder (e.g. anorexia, bulimia), or learning disability or a personality disorder that is considered by the investigator to interfere with the ability of the subject to adhere to the protocol (e.g. narcissistic personality, borderline personality disorder)
- Change in medication dose and/or frequency within the last 6 weeks. Participants must be on stable medications for 6 weeks prior to enrollment.
- Plans to change medication dose/frequency during the course of the study. Must plan to remain on stable dose for the duration of the study, unless otherwise indicated by their provider during the course of the study.
Show all 21Show fewer
- Plans to take vitamins and/or mineral supplements during the study. Must refrain for the duration of the study
- Unable to complete MRI scans
- Is a woman who is pregnant or breast feeding
- Plans to conceive a child while enrolled in this study or within 3 months after the last dose of the keto-like supplement
- Has received an investigational drug/vaccines, used an invasive investigational medical device within 60 days before the planned first dose of the keto-like supplement or has participated in 2 or more interventional clinical studies in the previous 1 year, or is currently enrolled in any drug or non-drug interventional study.
- Has had major surgery, (i.e. requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time they are expected to participate in the study.
- Intake of Omega 3 fatty acids (DHA, EPA, fish oil supplements)
- Significant cognitive impairment, clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study
- Known metabolic disorders (e.g., fatty acid oxidation disorders, ketolysis/ketogenesis or glucogenesis disorder, hyperinsulinism (e.g., pancreatic neuroendocrine tumor), pyruvate carboxylase deficiency, Type 1 and Type 2 diabetes
- Allergy to Stevia sweetener, malic acid or orange flavoring
- Concern for inability to maintain adherence to the keto-like supplement administration protocol
- Currently practicing a ketogenic or paleo diet or planning to do so during the study period.
- Change in body weight of more than 5 kg within one month before the start of the intervention
- Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study
- Contraindications to MRI examinations [persons with metallic implants (e.g., intracranial metal clips) and carriers of electronic devices (e.g., pacemaker) or persons with claustrophobia]
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
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
Teresa Victor, PhD, 918-502-5108, tvictor@laureateinstitute.org
Colleen McCallum, 918-502-5180
About this study
Official title: Exploratory Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of a Keto-Like Supplement in Depressed Patients on Functional Brain Responses to Positive and Negative Stimuli
This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours.
- Conditions
- Depression
- Being tested
- Keto-like supplement, Placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keto-like supplementDietary supplement
Participants will consume 9.25g stick packs of the keto-like supplement dissolved in water 3 times per day for 8 weeks.
PlaceboDietary supplement
Participants will consume 9.25g stick packs of placebo dissolved in water 3 times per day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Keto-like supplement | Active comparator | Participants will receive standardized 9.25g stick packs of the keto-like supplement. The study participants will take one of these stick packs dissolved in water three times a day (morning, noon, and evening) for 8 weeks. Receives: Dietary Supplement: Keto-like supplement |
| Placebo | Placebo comparator | Participants will receive standardized 9.25g stick packs of placebo. The study participants will take one of these stick packs dissolved in water three times a day (morning, noon, and evening) for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD response during Monetary Incentive Delay Task
P5vP0 contrast in the nucleus accumbens during the Monetary Incentive Delay Task
Measured: week 0 pre, week 0 post, week 8
Secondary outcomes (1)
BOLD response during Adjective Task
SELFvWORD contrast in the medial prefrontal cortex during the Adjective task
Measured: week 0 pre, week 0 post, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start9 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
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.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Paulus, MD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263660
- Sponsor's protocol ID
- 2022-007
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of a Keto-Like Supplement in Depressed Patients on Functional Brain Responses to Positive and Negative Stimuli
- ClinicalTrials.gov ID
- NCT06263660
- Acronym / sponsor ID
- 2022-007
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Feb 2024 (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.
This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keto-like supplement | Active comparator | Dietary Supplement: Keto-like supplementParticipants will receive standardized 9.25g stick packs of the keto-like supplement. The study participants will take one of these stick packs dissolved in water three times a day (morning, noon, and evening) for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will receive standardized 9.25g stick packs of placebo. The study participants will take one of these stick packs dissolved in water three times a day (morning, noon, and evening) for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Meets the Diagnostic and statistical manual - 5 (DSM-5) diagnostic criteria for MDD without psychotic features (past or present), as confirmed by the M.I.N.I v7.0
- PHQ-9 score of ≥10
- C-Reactive Protein (CRP) value > 1
- Age 18-65
- Consent ability and written consent
Key exclusion criteria (21 listed)
- Has a current or recent history of clinically significant suicidality
- Has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 12 months before screening
- Has positive test result(s) for alcohol or drugs of abuse (including methadone, opiates, cocaine, cannabinoids, amphetamine/methamphetamine and ecstasy)
- Has a current diagnosis of a psychotic disorder (e.g. schizophrenia, bipolar disorder), an eating disorder (e.g. anorexia, bulimia), or learning disability or a personality disorder that is considered by the investigator to interfere with the ability of the subject to adhere to the protocol (e.g. narcissistic personality, borderline personality disorder)
- Change in medication dose and/or frequency within the last 6 weeks. Participants must be on stable medications for 6 weeks prior to enrollment.
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 |
|---|---|---|
| Keto-like supplementParticipants will consume 9.25g stick packs of the keto-like supplement dissolved in water 3 times per day for 8 weeks. | Dietary supplement | Keto-like supplement |
| PlaceboParticipants will consume 9.25g stick packs of placebo dissolved in water 3 times per day for 8 weeks. | Dietary supplement | Placebo |
Primary outcome
BOLD response during Monetary Incentive Delay Task
Time frame: week 0 pre, week 0 post, week 8
P5vP0 contrast in the nucleus accumbens during the Monetary Incentive Delay Task
1 secondary outcome
BOLD response during Adjective Task
Time frame: week 0 pre, week 0 post, week 8
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 20 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Martin Paulus, MD principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Keto-like supplement in people with Depression, run by Laureate Institute for Brain Research, Inc. 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 21 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 20 Apr 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Teresa Victor, PhD (918-502-5108, tvictor@laureateinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD response during Monetary Incentive Delay Task (time frame: week 0 pre, week 0 post, week 8). 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 20 Apr 2026.