Schizophrenia and Related DisordersKISSeSNCT06426134
Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS
A study testing (R)-3-hydroxybutyl (R)-3-hydroxybutyrate) and Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride in people with Schizophrenia and Related Disorders and Psychosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to learn if a ketone drink can improve signs and symptoms of patients with a schizophrenia-spectrum disorder (SSD), or a bipolar-spectrum disorder (BD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia and Related Disorders, Psychosis, Bipolar and Related Disorders
- What is being tested?
- (R)-3-hydroxybutyl (R)-3-hydroxybutyrate) and Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2024to 17 Apr 2026
- 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
- Patients with a first-episode psychosis (underlying schizophrenia-spectrum disorder), or patients with a (hypo)manic or depressive episode (underlying bipolar disorder)
- Age >= 18 years old
- Receiving standard care (including antipsychotic and mood stabilizing medication)
- Mentally competent to give informed consent:
Who cannot join
- Substance use as cause of psychosis or (hypo)mania
- Substance use (other than nicotine) in the week prior to study onset
- Intellectual disability
- Diabetes mellitus (type 1 or type 2)
- Metabolic disease impacting ketone metabolism (NB: these are rare disorders diagnosed during childhood)
- Liver disease
Show all 10Show fewer
- Kidney disease
- Cardiovascular disease
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, dept. Psychiatry
Amsterdam, North Holland, 1105 AZ
About this study
Official title: Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders
The goal of this clinical trial is to learn if a ketone drink can improve signs and symptoms of patients with a schizophrenia-spectrum disorder (SSD), or a bipolar-spectrum disorder (BD).
The main questions it aims to answer are:
Read more
Does a ketone drink improve information processing in patients with SSD/BD?
Other questions it aims to answer are:
Does a ketone drink improve cognitive functioning in patients with SSD/BD? Does a ketone drink improve metabolism and inflammation in patients with SSD/BD? Does a ketone drink affect circadian rhythm in patients with SSD/BD?
Research will compare the effects of the ketone drink with that of an isocaloric carbohydrate drink in the same patients ('cross-over').
Participants will:
- drink a ketone drink and (after a wash-out period) an isocaloric control drink (randomized order); after each drink:
- EEG/EMG to determine information-processing parameters (PPI and P300)
- cognitive tests
- visual analog scale of mood, energy levels, ability to focus
- indirect calorimetry to determine use of energy substrate
- blood draws
- for 5 consecutive days:
- wear a continuous glucose monitor (CGM)
- wear a non-invasive passive sweat biomarker sensor (EnLiSense device)
- register a diet and nicotine diary
- saliva sampling (max. 5x/day)
- Conditions
- Schizophrenia and Related Disorders, Psychosis, Bipolar and Related Disorders, Manic Episode, Depressive Episode
- Being tested
- (R)-3-hydroxybutyl (R)-3-hydroxybutyrate), Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar and Related Disorders, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate)Dietary supplement
Also called delta G Ketones (dGK)
1x50g ingestion of pure dGK
Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chlorideOther
Also called Maurten Drink Mix 160
Isocaloric carbohydrate control (active control)
| Study group | Role | What they receive |
|---|---|---|
| dGK | Experimental | 1x50 g dGK ketone drink Receives: Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate) |
| isocaloric carb control | Active comparator | 1x isocaloric carbohydrate control drink Receives: Other: Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prepulse Inhibition (PPI) - change dGK vs isocaloric control
PPI: an event-related potential (ERP) representing information processing (known to be disrupted in schizophrenia and bipolar disorder).
The PPI task is an auditory paradigm featuring a total of 10 trials split evenly into two conditions: prepulse (PP) and non-prepulse (NP) in blocks. Startle pulses are 100dB at 40 ms, which is shown to provide significant startle visible in EEG126. Prepulse stimuli are 70 dB and 50 ms in duration, presented 50ms prior to the startle pulse. There is a 12 to 18 (avg: 15 s) interstimulus interval. All stimuli are white-noise blips. A calibrated apparatus is used to present the stimuli. Total estimated time is 20 min.
Measured: measured 45 minutes (Tmax) after ingestion of intervention 1 (dGK) and 45 minuts after ingestion of intervention 2 (isocaloric carb control)
Secondary outcomes (15)
P300 Event Related Potential (change dGK vs isocaloric control)
The P300 task consists of 160 stimuli in the oddball paradigm and requires the subjects to press a button on detection of the rare target (32/160). The common nontarget stimuli are 500 Hz, 100 ms duration. The rare target stimuli are 700 Hz. Both are 100 ms duration at 80 dB with variable interstimulus interval of 1.2 to 1.5 s. Preceded by 10 practice trials. This task has minimal burden and requires about 10 minutes.
Measured: measured 65-75 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after PPI.
Cognitive test: 15 Word Test (15WT) - change dGK vs isocaloric control
15WT is a measure of verbal/episodic memory. The 15WT consists of 15 words, which have to be learned during three trials. After every trial the respondent is asked to recall as many words as possible. After a distraction period of 20 minutes, the respondent is asked to name the words they have learned before, again.
Immediate recall after 1 test: maximum 15 words (minimum 0) Immediate recall after 3 test: maximum 45 words (minimum 0).
Retention score after 20 minutes:
- percentage of correctly remembered words in the delayed recall-trial, relative to the number of words correctly remembered in the third immediate recall-trial
- percentage of correctly remembered words in the delayed recall-trial, relative to the maximum score in the immediate recall-trials
Higher 15WT scores indicate better verbal/episodic memory, lower scores the opposite.
Measured: measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after P300.
Cognitive test: Trail Making Test A (TMT-A) - change dGK vs isocaloric control
TMT-A is a measure of (visual) attention. TMT-A outcome is the duration of time required to finalize test (including the time needed for the correction of errors prompted by the examiner), with a maximum of 5 minutes.
The average TMT-A score in healthy adults is 29 seconds; a deficient score is greater than 78 seconds.
Higher scores on TMT-A indicate worse (visual) attention.
Measured: measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after P300.
Cognitive test: Trail-Making Test B (TMT-B) - (change dGK vs isocaloric control)
TMT-B is a measure of (frontal) executive functioning. TMT-B outcome is the duration of time required to finalize test (including the time needed for the correction of errors prompted by the examiner), with a maximum of 5 minutes.
Average TMT-B score is 75 seconds; a deficient score is greater than 273 seconds.
Higher scores on TMT-B indicate worse (frontal) executive functioning.
Measured: measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after TMT-A.
Cognitive test: Digit Span Test (DST) (change dGK vs isocaloric control)
DST is a measure for working memory. DST outcome is the maximum number of sequential digits correctly reproduced. In average healthy adults, the digit span is around 7 +/- 2. Minimum score is 0, maximum score is 9.
Lower DST score indicate worse working memory.
Measured: measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after TMT-B.
Patient experience outcome on Mood, energy level, focus (change dGK vs isocaloric control)
visual analog scale (VAS) is used with a scale of 0 to 10 to measure patient-experiences effects of the interventions on their mood (0=extremely depression, 10 = extremely happy/euforic), energy level (0=completely exhauster, 10= extremely energetic) and ability to focus (0=completely unable to focus, 10=perfect focus).
Measured: measured circa 120 minutes after ingestion of intervention 1 (dGK) and circa 120 minutes after ingestion of intervention 2 (isocaloric carb control)
Immune function: blood markers (change dGK vs isocaloric control)
sequential blood sampling through intravenous line: concentration (pg/ml) of inflammatory biomarkers relevant for immune function:
- IL-1b
- IL-6
- IL-8
- IL-10
- TNF-a
- IFN-g
- hsCRP
Comparison between dGK and isocaloric control at the same time points (see below).
Measured: first blood sample before ingestion (dGK or isocaloric control) (T0), then every 20 minutes in first hour after ingestion; afterwards every 30 minutes (max. 3 hours)
Immune function: blood RNA markers (change dGK vs isocaloric control)
RNA expression analysis (immune panel nCounter, Nanostring) in whole blood: comparison dGK vs isocaloric control only at T0 plus 90 minutes.
Measured: first blood sample before ingestion (dGK or isocaloric control) (T0), next at T0+90 minutes
Immune function: passive sweat IL-6 (change dGK vs isocaloric control)
continuous measurement of IL-6 (pg/ml) in passive sweat (EnLiSense device)
Measured: Full 5 days of the study
Immune function: passive sweat TNF-a (change dGK vs isocaloric control)
continuous measurement of TNF-a (pg/ml)in passive sweat (EnLiSense device)
Measured: Full 5 days of study
Metabolic function: Indirect Calorimetry (change dGK vs isocaloric control)
Resting energy expenditure (REE) is measured by gaseous exchange (indirect calorimetry). Oxygen consumption and CO2 production are measured during 20 minutes using a ventilated hood system (Q-NRG, Cosmed). Subjects lie flat on their backs and breathe into a canopy for 20 minutes. REE and Respiratory Quotient (RQ) are calculated with these measurements. The RQ represents the ratio of CO2 exhaled to the amount of 02 consumed by the individual and represents whole body substrate oxidation (glucose, fat and protein oxidation).
Measured: circa 90-120 minutes after ingestion of intervention 1 (dGK) and intervention 2 (isocaloric control); directly after finalizing cognitive tests.
Metabolic function: blood biomarkers - change dGK vs isocaloric control
Sequential blood sampling through intravenous line, to determine the plasma and serum concentrations of:
- Glucose
- Ketones
- acylcarnitine profile
- growth hormone (GH)
- superoxide dismutase (SOD)
- gluthione S-transferase (GST)
- soluble intercellular adhesion molecule 1 (sICAM1)
Comparison between dGK and isocaloric control at the same time points (see below).
Measured: first blood sample before ingestion (both dGK and isocaloric control) (T0), then every 20 minutes in first hour after ingestion; afterwards every 30 minutes (max. 3 hours)
Metabolic function: continuous glucose monitor (CGM) - change dGK vs isocaloric control
continuous glucose monitor (CGM; Abbott Libre Sense); continuous concentration in mM.
Measured: Full 5 days of the study.
Circadian rhythm: passive sweat cortisol (change dGK vs isocaloric control)
continuous measurement of cortisol (pg/ml) in passive sweat (EnLiSense device)
Measured: Full 5 days of study
Circadian rhythm: passive sweat melatonin (change dGK vs isocaloric control)
continuous measurement of melatonin (pg/ml) in passive sweat (EnLiSense device)
Measured: Full 5 days of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Dec 2024
- Primary completion17 Apr 2026
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Parnassia Groep, The University of Texas at Dallas, University of Alberta, EnLiSense
- Responsible party
- Principal investigator, Karin Huizer, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Karin Huizer, MD/PhD, Principal investigator, Parnassia Groep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426134
- Sponsor's protocol ID
- NL83836.018.23
- Other IDs
- 2024.0100
- Acronym
- KISSeS
- Status last verified
- Apr 2026
- First submitted
- 8 May 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dielemans DA, Yurtkap Y, van der Pluijm M, Soeters MR, Oranje B, Smit DJ, Ziermans T, van Tricht MJ, Muthukumar S, Prasad S, van der Mieden van Opmeer RL, Dekeyster E, Kamperman AM, Dyck JR, Rosema BS, Hoekstra R, Kupka RW, de Haan L, van Beveren NJ, Huizer K. The Effect of Exogenous Ketones on Signs and Symptoms of Schizophrenia Spectrum and Bipolar Disorders: Study Protocol for a Triple-Blind, Randomized, Controlled Crossover Pilot Study. Curr Dev Nutr. 2025 May 24;9(6):107480. doi: 10.1016/j.cdnut.2025.107480. eCollection 2025 Jun.
PubMed 40568354
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders
- ClinicalTrials.gov ID
- NCT06426134
- Acronym / sponsor ID
- KISSeS / NL83836.018.23
- Conditions
- Schizophrenia and Related Disorders, Psychosis, Bipolar and Related Disorders, Manic Episode, Depressive Episode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Parnassia Groep, The University of Texas at Dallas, University of Alberta, EnLiSense
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 23 May 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.
The goal of this clinical trial is to learn if a ketone drink can improve signs and symptoms of patients with a schizophrenia-spectrum disorder (SSD), or a bipolar-spectrum disorder (BD).
The main questions it aims to answer are:
Does a ketone drink improve information processing in patients with SSD/BD?
Other questions it aims to answer are:
Does a ketone drink improve cognitive functioning in patients with SSD/BD? Does a ketone drink improve metabolism and inflammation in patients with SSD/BD? Does a ketone drink affect circadian rhythm in patients with SSD/BD?
Research will compare the effects of the ketone drink with that of an isocaloric carbohydrate drink in the same patients ('cross-over').
Participants will:
- drink a ketone drink and (after a wash-out period) an isocaloric control drink (randomized order); after each drink:
- EEG/EMG to determine information-processing parameters (PPI and P300)
- cognitive tests
- visual analog scale of mood, energy levels, ability to focus
- indirect calorimetry to determine use of energy substrate
- blood draws
- for 5 consecutive days:
- wear a continuous glucose monitor (CGM)
- wear a non-invasive passive sweat biomarker sensor (EnLiSense device)
- register a diet and nicotine diary
- saliva sampling (max. 5x/day)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dGK | Experimental | Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate)1x50 g dGK ketone drink |
| isocaloric carb control | Active comparator | Other: Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride1x isocaloric carbohydrate control drink |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a first-episode psychosis (underlying schizophrenia-spectrum disorder), or patients with a (hypo)manic or depressive episode (underlying bipolar disorder)
- Age >= 18 years old
- Receiving standard care (including antipsychotic and mood stabilizing medication)
- Mentally competent to give informed consent:
Key exclusion criteria (10 listed)
- Substance use as cause of psychosis or (hypo)mania
- Substance use (other than nicotine) in the week prior to study onset
- Intellectual disability
- Diabetes mellitus (type 1 or type 2)
- Metabolic disease impacting ketone metabolism (NB: these are rare disorders diagnosed during childhood)
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 |
|---|---|---|
| (R)-3-hydroxybutyl (R)-3-hydroxybutyrate)Also: delta G Ketones (dGK)1x50g ingestion of pure dGK | Dietary supplement | dGK |
| Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chlorideAlso: Maurten Drink Mix 160Isocaloric carbohydrate control (active control) | Other | isocaloric carb control |
Primary outcome
Prepulse Inhibition (PPI) - change dGK vs isocaloric control
Time frame: measured 45 minutes (Tmax) after ingestion of intervention 1 (dGK) and 45 minuts after ingestion of intervention 2 (isocaloric carb control)
PPI: an event-related potential (ERP) representing information processing (known to be disrupted in schizophrenia and bipolar disorder). The PPI task is an auditory paradigm featuring a total of 10 trials split evenly into two conditions: prepulse (PP) and non-prepulse (NP) in blocks. Startle pulses are 100dB at 40 ms, which is shown to provide significant startle visible in EEG126. Prepulse stimuli are 70 dB and 50 ms in duration, presented 50ms prior to the startle pulse. There is a 12 to 18 (avg: 15 s) interstimulus interval. All stimuli are white-noise blips. A calibrated apparatus is used to present the stimuli. Total estimated time is 20 min.
15 secondary outcomes
P300 Event Related Potential (change dGK vs isocaloric control)
Time frame: measured 65-75 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after PPI.
Cognitive test: 15 Word Test (15WT) - change dGK vs isocaloric control
Time frame: measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after P300.
Cognitive test: Trail Making Test A (TMT-A) - change dGK vs isocaloric control
Time frame: measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after P300.
Cognitive test: Trail-Making Test B (TMT-B) - (change dGK vs isocaloric control)
Time frame: measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after TMT-A.
Cognitive test: Digit Span Test (DST) (change dGK vs isocaloric control)
Time frame: measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after TMT-B.
Patient experience outcome on Mood, energy level, focus (change dGK vs isocaloric control)
Time frame: measured circa 120 minutes after ingestion of intervention 1 (dGK) and circa 120 minutes after ingestion of intervention 2 (isocaloric carb control)
Immune function: blood markers (change dGK vs isocaloric control)
Time frame: first blood sample before ingestion (dGK or isocaloric control) (T0), then every 20 minutes in first hour after ingestion; afterwards every 30 minutes (max. 3 hours)
Immune function: blood RNA markers (change dGK vs isocaloric control)
Time frame: first blood sample before ingestion (dGK or isocaloric control) (T0), next at T0+90 minutes
Immune function: passive sweat IL-6 (change dGK vs isocaloric control)
Time frame: Full 5 days of the study
Immune function: passive sweat TNF-a (change dGK vs isocaloric control)
Time frame: Full 5 days of study
Metabolic function: Indirect Calorimetry (change dGK vs isocaloric control)
Time frame: circa 90-120 minutes after ingestion of intervention 1 (dGK) and intervention 2 (isocaloric control); directly after finalizing cognitive tests.
Metabolic function: blood biomarkers - change dGK vs isocaloric control
Time frame: first blood sample before ingestion (both dGK and isocaloric control) (T0), then every 20 minutes in first hour after ingestion; afterwards every 30 minutes (max. 3 hours)
Metabolic function: continuous glucose monitor (CGM) - change dGK vs isocaloric control
Time frame: Full 5 days of the study.
Circadian rhythm: passive sweat cortisol (change dGK vs isocaloric control)
Time frame: Full 5 days of study
Circadian rhythm: passive sweat melatonin (change dGK vs isocaloric control)
Time frame: Full 5 days of study
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 27 Apr 2026.
- Derived from this study: PubMed 40568354Dielemans DA, Yurtkap Y, van der Pluijm M, Soeters MR, Oranje B, Smit DJ, Ziermans T, van Tricht MJ, Muthukumar S, Prasad S, van der Mieden van Opmeer RL, Dekeyster E, Kamperman AM, Dyck JR, Rosema BS, Hoekstra R, Kupka RW, de Haan L, van Beveren NJ, Huizer K. The Effect of Exogenous Ketones on Signs and Symptoms of Schizophrenia Spectrum and Bipolar Disorders: Study Protocol for a Triple-Blind, Randomized, Controlled Crossover Pilot Study. Curr Dev Nutr. 2025 May 24;9(6):107480. doi: 10.1016/j.cdnut.2025.107480. eCollection 2025 Jun.
Related trials for Schizophrenia and Related Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Schizophrenia, Schizo Affective Disorder
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
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.
Karin Huizer, MD/PhD principal investigator
Parnassia Groep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (R)-3-hydroxybutyl (R)-3-hydroxybutyrate) and Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride in people with Schizophrenia and Related Disorders and Psychosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 4 inclusion and 10 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 27 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 Netherlands. 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?
Prepulse Inhibition (PPI) - change dGK vs isocaloric control (time frame: measured 45 minutes (Tmax) after ingestion of intervention 1 (dGK) and 45 minuts after ingestion of intervention 2 (isocaloric carb control)). 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 NCT06426134, which also lists 1 linked publication.
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 27 Apr 2026.