Psychosis; AcutePsyDietNCT03873922
Ketogenic Diet for Psychotic Disorders
A study testing Ketogenic diet intervention in people with Psychosis; Acute and Psychosis, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Disturbances in glucose metabolism and glutamate neurotransmission feature in the pathophysiology of psychotic disorders. Ketogenic diet (KD) is a high-fat, low-carbohydrate diet that restricts glucose and forces metabolism of ketones, which serve as alternative energy substrates for the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis; Acute, Psychosis, Psychotic Disorders
- What is being tested?
- Ketogenic diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 15 Mar 2021to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old patient with psychotic symptoms / diagnosed psychotic disorder (ICD-10 diagnoses F20-F29)
Who cannot join
- BMI <18.5
- Diabetes mellitus (with or without insulin treatment)
- Inability to provide informed consent or to participate due to acute medical conditions, such as severe and acute psychotic symptoms or acute suicidality
- Impairments in vision, audition or immobility
- Pregnancy
- Diagnosed current eating disorder
Show all 11Show fewer
- Diagnosed Inflammatory Bowel Disease (IBD)
- Severe alcohol or substance abuse
- Decompensated cardial insufficiency
- Infrequent/rare metabolic disorders, such as porphyria, disturbances in fatty acid oxidation or deficiency of CTT1, CPTII, carnitine or pyruvate carboxylase
- changes have occurred in psychotropic medications during the last 4 weeks
Trial locations and contacts
1 site in 1 country.
Felice Jacka, Professor contact
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital, Department of Psychiatry
Kuopio
Anu Ruusunen, PhD
About this study
Official title: Dietary Intervention for Psychotic Disorders: a Pilot Intervention Study of Ketogenic Diet for Psychotic Symptoms - PsyDiet Pilot Study
Disturbances in glucose metabolism and glutamate neurotransmission feature in the pathophysiology of psychotic disorders. Ketogenic diet (KD) is a high-fat, low-carbohydrate diet that restricts glucose and forces metabolism of ketones, which serve as alternative energy substrates for the brain. KD is an established treatment for intractable epilepsy. However, we lack the randomized controlled trials (RCT) evidence regarding potential effects of KD on psychotic symptoms in humans.
This randomised, controlled pilot study aims to investigate:
Read more
- feasibility of a Modified Ketogenic Diet (MKD) intervention protocol in psychotic inpatients,
- potential impact of MKD intervention on psychotic symptoms, depressive and anxiety symptoms, and functioning in patients with psychotic symptoms / psychotic disorder.
A 6-week randomised KD pilot study will be carried out in psychotic inpatients (aimed n=40) at Niuvanniemi Hospital and Kuopio University Hospital, Finland. In the KD group, carbohydrate consumption is limited to 15-20 g/day to activate ketosis. The control group will have their ordinary hospital meals. A number of different assessment will be carried out at time points 0, 1 week, 3 weeks and 6 weeks.
Read the detailed description
Disturbances in glucose metabolism and glutamate neurotransmission feature in the pathophysiology of psychotic disorders. Ketogenic diet (KD) is a high-fat, low-carbohydrate diet that restricts glucose and forces metabolism of ketones, which serve as alternative energy substrates for the brain. KD is an established treatment for intractable epilepsy. However, we lack the RCT evidence regarding potential effects of KD on psychotic symptoms in humans.
This randomised, controlled pilot study aims to investigate:
- feasibility of a Modified Ketogenic Diet (MKD) intervention protocol in psychotic inpatients,
- potential impact of MKD intervention on psychotic symptoms, depressive and anxiety symptoms, and functioning in patients with psychotic symptoms / psychotic disorder.
A 6-week randomised KD pilot study will be carried out in psychotic inpatients (aimed n=40) at Niuvanniemi Hospital and Kuopio University Hospital, Finland. In the KD group, carbohydrate consumption is limited to 15-20 g/day to activate ketosis. The control group will have their ordinary hospital meals. The Structured Clinical Interview for DSM Axis I disorders (SCID-I), and the Positive and Negative Syndrome Scale (PANSS) will assess current psychotic disorders and psychotic symptoms, respectively. Blood glucose, lipid, and ketone body levels, and weight will be measured. Background variables (socioeconomic factors, comorbidities, obtained treatments including medications, and health behaviours including diet) will be documented.
- Conditions
- Psychosis; Acute, Psychosis, Psychotic Disorders, Schizophrenia
- Being tested
- Ketogenic diet intervention
- Keywords
- Ketogenic diet, Intervention, Ketosis, Feasibility, Psychosis, Psychotic symptoms, Schizophrenia, Dietary intervention
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic diet interventionOther
Also called KD, Modified Ketogenic Diet
Ketogenic, really low carbohydrate containing (15-20 g/day), meals will be offered to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet intervention | Experimental | Ketogenic meals will be offered for the participants during the trial. Receives: Other: Ketogenic diet intervention |
| Control group | No intervention | Conventional hospital meals as usual will be offered during the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to 6 weeks.
Change in positive and negative psychotic symptoms, assessed at time points baseline, 1, 3 and 6 weeks. The participants are rated from 1 to 7 on 30 different symptoms based on the interview. PANSS Total score minimum is 30, maximum is 210. As 1 rather than 0 is given as the lowest score for each item, a participant can not score lower than 30 for the total PANSS score. Scores are given separately for the positive items, negative items, and general psychopathology scales which altogether (summarized) create a total PANSS score. Higher values represent a worse outcome.
Measured: The change from baseline to the end of the intervention (6 weeks) OR if discharged earlier, from baseline to the latest study assessment time point (1 or 3 weeks)
Feasibility 1, defined by modified ketogenic diet related experiences, challenges and potential adverse effects during the intervention
Feasibility will be assessed by modified ketogenic diet related experiences, challenges and potential adverse effects by a Questionnaire of potential side effects and acceptance of MKD during the trial.
Measured: Potential adverse effects during the entire trial will be evaluated (from baseline to 1, 3 and 6 weeks), as observed adverse effects may vary between study time points and status of ketosis
Feasibility 2, defined by percentage of study participants who discontinue diet and percentage of participants reaching ketosis (measured by blood ketone body levels)
We will screen blood ketone body levels daily (MKD participants) or weekly (control participants). If participants in the MKD arm are not able to adhere to MKD, they will not reach ketosis or will not stay in ketosis. Feasibility will be defined by percentage of study participants reaching ketosis in the MKD group. In addition, drop-out rate of participants in each study arm will be calculated.
Measured: Percentage of participants reaching ketosis and staying in ketosis in the MKD group will be calculated at each time point (weeks 1, 3 and 6)
Secondary outcomes (4)
The change in Beck Depression Inventory (BDI) score from baseline to 6 weeks.
Change in depressive symptoms assessed by Beck Depression Inventory scores. BDI is a series of questions developed to measure the intensity, severity, and depth of depression in patients with psychiatric diagnoses. It is composed of 21 questions, each designed to assess a specific symptom. each with four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. Score range is 0-63. Higher values represent a worse outcome.
Measured: Change in BDI score from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (3 weeks)
The change in Beck Anxiety Inventory (BAI) score from baseline to 6 weeks
Change in anxiety symptoms assessed by BAI scores. BAI evaluates both physiological and cognitive symptoms of anxiety and item overlap with other self report depression inventories is minimised. The BAI consists of 21 items; each item is descriptive of a symptom of anxiety and is rated on a scale of 0 to 3. Thus, the score range is from 0 to 63. Higher values represent a worse outcome.
Measured: Change in BAI score from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (3 weeks)
The change in Structured Clinical Interview for DSM Axis I disorders (SCID-I) diagnosis from baseline to 6 weeks
The Structured Clinical Interview for DSM Axis I disorders assessing psychotic symptoms (SCID-I) is a validated semi-structured clinical interview (the gold standard tool for psychiatric assessment in a research setting). SCID-I will be used to assess for past and current psychotic disorders at the beginning and at the 6 week of intervention.
Measured: Change in SCID-I diagnosis from baseline to 6 weeks
The change in the Global Assessment of Functioning score from baseline to 6 weeks.
Change in The Global Assessment of Functioning (GAF). GAF interview will be conducted at each study time point (baseline, 1, 3 and 6 weeks). GAF scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect his or her day-to-day life on a scale of 0 to 100. Higher values represent a worse outcome.
Measured: Change in GAF score from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (1 or 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start15 Mar 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosis; AcuteStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After baseline examinations, participants will be randomized to receive either ketogenic meals or conventional hospital meals during the study (maximum of six weeks). Otherwise treatment as usual.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Deakin University
- Responsible party
- Sponsor
- Investigators
- Anu Ruusunen, PhD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873922
- Sponsor's protocol ID
- KUH5703458
- Acronym
- PsyDiet
- Status last verified
- Mar 2024
- First submitted
- 28 Aug 2018
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be decided shortly.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention for Psychotic Disorders: a Pilot Intervention Study of Ketogenic Diet for Psychotic Symptoms - PsyDiet Pilot Study
- ClinicalTrials.gov ID
- NCT03873922
- Acronym / sponsor ID
- PsyDiet / KUH5703458
- Conditions
- Psychosis; Acute, Psychosis, Psychotic Disorders, Schizophrenia
- Keywords
- Ketogenic diet, Intervention, Ketosis, Feasibility, Psychosis, Psychotic symptoms, Schizophrenia, Dietary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Deakin University
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Mar 2019 (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.
Disturbances in glucose metabolism and glutamate neurotransmission feature in the pathophysiology of psychotic disorders. Ketogenic diet (KD) is a high-fat, low-carbohydrate diet that restricts glucose and forces metabolism of ketones, which serve as alternative energy substrates for the brain. KD is an established treatment for intractable epilepsy. However, we lack the randomized controlled trials (RCT) evidence regarding potential effects of KD on psychotic symptoms in humans.
This randomised, controlled pilot study aims to investigate:
- feasibility of a Modified Ketogenic Diet (MKD) intervention protocol in psychotic inpatients,
- potential impact of MKD intervention on psychotic symptoms, depressive and anxiety symptoms, and functioning in patients with psychotic symptoms / psychotic disorder.
A 6-week randomised KD pilot study will be carried out in psychotic inpatients (aimed n=40) at Niuvanniemi Hospital and Kuopio University Hospital, Finland. In the KD group, carbohydrate consumption is limited to 15-20 g/day to activate ketosis. The control group will have their ordinary hospital meals. A number of different assessment will be carried out at time points 0, 1 week, 3 weeks and 6 weeks.
Detailed description
Disturbances in glucose metabolism and glutamate neurotransmission feature in the pathophysiology of psychotic disorders. Ketogenic diet (KD) is a high-fat, low-carbohydrate diet that restricts glucose and forces metabolism of ketones, which serve as alternative energy substrates for the brain. KD is an established treatment for intractable epilepsy. However, we lack the RCT evidence regarding potential effects of KD on psychotic symptoms in humans.
This randomised, controlled pilot study aims to investigate:
- feasibility of a Modified Ketogenic Diet (MKD) intervention protocol in psychotic inpatients,
- potential impact of MKD intervention on psychotic symptoms, depressive and anxiety symptoms, and functioning in patients with psychotic symptoms / psychotic disorder.
A 6-week randomised KD pilot study will be carried out in psychotic inpatients (aimed n=40) at Niuvanniemi Hospital and Kuopio University Hospital, Finland. In the KD group, carbohydrate consumption is limited to 15-20 g/day to activate ketosis. The control group will have their ordinary hospital meals. The Structured Clinical Interview for DSM Axis I disorders (SCID-I), and the Positive and Negative Syndrome Scale (PANSS) will assess current psychotic disorders and psychotic symptoms, respectively. Blood glucose, lipid, and ketone body levels, and weight will be measured. Background variables (socioeconomic factors, comorbidities, obtained treatments including medications, and health behaviours including diet) will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After baseline examinations, participants will be randomized to receive either ketogenic meals or conventional hospital meals during the study (maximum of six weeks). Otherwise treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet intervention | Experimental | Other: Ketogenic diet interventionKetogenic meals will be offered for the participants during the trial. |
| Control group | No intervention | –Conventional hospital meals as usual will be offered during the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥ 18 years old patient with psychotic symptoms / diagnosed psychotic disorder (ICD-10 diagnoses F20-F29)
Key exclusion criteria (11 listed)
- BMI <18.5
- Diabetes mellitus (with or without insulin treatment)
- Inability to provide informed consent or to participate due to acute medical conditions, such as severe and acute psychotic symptoms or acute suicidality
- Impairments in vision, audition or immobility
- Pregnancy
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 diet interventionAlso: KD, Modified Ketogenic DietKetogenic, really low carbohydrate containing (15-20 g/day), meals will be offered to the participants. | Other | Ketogenic diet intervention |
Primary outcome
The change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to 6 weeks.
Time frame: The change from baseline to the end of the intervention (6 weeks) OR if discharged earlier, from baseline to the latest study assessment time point (1 or 3 weeks)
Change in positive and negative psychotic symptoms, assessed at time points baseline, 1, 3 and 6 weeks. The participants are rated from 1 to 7 on 30 different symptoms based on the interview. PANSS Total score minimum is 30, maximum is 210. As 1 rather than 0 is given as the lowest score for each item, a participant can not score lower than 30 for the total PANSS score. Scores are given separately for the positive items, negative items, and general psychopathology scales which altogether (summarized) create a total PANSS score. Higher values represent a worse outcome.
Feasibility 1, defined by modified ketogenic diet related experiences, challenges and potential adverse effects during the intervention
Time frame: Potential adverse effects during the entire trial will be evaluated (from baseline to 1, 3 and 6 weeks), as observed adverse effects may vary between study time points and status of ketosis
Feasibility will be assessed by modified ketogenic diet related experiences, challenges and potential adverse effects by a Questionnaire of potential side effects and acceptance of MKD during the trial.
Feasibility 2, defined by percentage of study participants who discontinue diet and percentage of participants reaching ketosis (measured by blood ketone body levels)
Time frame: Percentage of participants reaching ketosis and staying in ketosis in the MKD group will be calculated at each time point (weeks 1, 3 and 6)
We will screen blood ketone body levels daily (MKD participants) or weekly (control participants). If participants in the MKD arm are not able to adhere to MKD, they will not reach ketosis or will not stay in ketosis. Feasibility will be defined by percentage of study participants reaching ketosis in the MKD group. In addition, drop-out rate of participants in each study arm will be calculated.
4 secondary outcomes
The change in Beck Depression Inventory (BDI) score from baseline to 6 weeks.
Time frame: Change in BDI score from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (3 weeks)
The change in Beck Anxiety Inventory (BAI) score from baseline to 6 weeks
Time frame: Change in BAI score from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (3 weeks)
The change in Structured Clinical Interview for DSM Axis I disorders (SCID-I) diagnosis from baseline to 6 weeks
Time frame: Change in SCID-I diagnosis from baseline to 6 weeks
The change in the Global Assessment of Functioning score from baseline to 6 weeks.
Time frame: Change in GAF score from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (1 or 3 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: Undecided. Will be decided shortly.
Related trials for Psychosis; Acute
Recruiting
A Closed Unit Incorporating Soteria Elements Versus a Conventional Closed Psychiatric Ward
Psychotic Disorders
Recruiting
FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis
Delusional Disorder, Brief Psychotic Disorder
RecruitingPhase 1
A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
Schizophrenia
RecruitingPhase 3
Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
Schizophrenia
Not yet recruitingPhase 2
Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia Adults
Schizophrenia
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.
Felice Jacka, Professor contact
Anu Ruusunen, PhD principal investigator
Kuopio University Hospital
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 intervention in people with Psychosis; Acute and Psychosis, run by Kuopio University Hospital at 1 site in Finland.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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 Finland. 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 Anu Ruusunen, PhD (+358503871265, anu.ruusunen@uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to 6 weeks. (time frame: The change from baseline to the end of the intervention (6 weeks) OR if discharged earlier, from baseline to the latest study assessment time point (1 or 3 weeks)). The study lists 3 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 8 Mar 2024.