Schizophrenia and Disorders with Psychotic FeaturesKaSPNCT06872463
Karolinska Schizophrenia Project
An observational study of Schizophrenia and Disorders with Psychotic Features, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
KaSP is a multimodal observational study with the goal of clarifying underlying mechanisms that cause psychotic disorders, such as schizophrenia. Participants with psychotic symptoms are recruited early after first contact with health care, within 4 weeks of starting anti-psychotic medication, and are compared to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia and Disorders with Psychotic Features
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 25 Jan 2011to 31 Dec 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: FEP are recruited from psychiatry clinics in the greater Stockholm area. HC are recruited by advertisement.
Who may be able to join
- For FEP:
- Diagnosis as assessed using DSM-IV of one of the following: schizophrenia, schizophreniform psychosis, psychosis not otherwise specified (NOS), brief psychosis, schizoaffective syndrome, delusional disorder
- First exposure to anti-psychotic medication less than 4 weeks prior to inclusion
Who cannot join
- For FEP:
- Other dominant psychiatric illness deemed to be related to current psychotic symptoms
- For HC:
- A history of diagnosis of a major psychiatric disorder, including substance use disorders.
- Family history of psychotic disorders in first degree relatives.
- For all:
Show all 15Show fewer
- Evidence based on medical history, clinical signs, MRI or laboratory tests of clinically significant somatic disorder, or previous disorder with brain engagement (e.g. tumour, neuroinflammatory disease, epilepsy) or significant brain trauma.
- Exposure to an effective radiation dose of 25 mSv during the past year.
- Pregnancy, lactating or breastfeeding (women).
- Meets diagnostic criteria of substance use disorder (excluding nicotine dependence) as assessed using DSM-IV or as determined using repeated positive urine screens during the course of the study.
- Metallic object in the eye, or ferro/electromagnetic implants. History of claustrophobic anxiety during MRI.
- Symptoms of severe bacterial, fungal, or viral infection (including upper respiratory tract infection), with systemic effects as detected by e.g. fever, within 7 days prior to inclusion.
- Treatment with any antihemostatic medication within 2 weeks of lumbar puncture and arterial line placement of either the baseline or 1 year follow-up.
- Blood donation (1 unit or more) within 90 days prior to Screening, plasma donation from 1 week prior to Screening, and platelet donation from 6 weeks prior to inclusion.
- Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrollment. This may include very high symptom severity or signs of aggressiveness and hostility.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
SLSO Psykiatri Stockholm in collaboration w Karolinska Institutet
Stockholm
Carl M Sellgren, MD, PhD, 0046702127287, carl.sellgren@ki.se
About this study
Official title: Brain Immunoactivation in Drug-Naive Patients with First Episode Schizophrenia
KaSP is a multimodal observational study with the goal of clarifying underlying mechanisms that cause psychotic disorders, such as schizophrenia. Participants with psychotic symptoms are recruited early after first contact with health care, within 4 weeks of starting anti-psychotic medication, and are compared to controls without psychiatric diagnoses on several measures.
Read the detailed description
KaSP aims to recruit 120 patients sparsely medicated or drug-naive first episode psychosis (FEP) individuals, along with 80 healthy controls.
Participants undergo the following assessments and measurements:
- Clinical assessment
- Cognitive testing
- Lab results from cerebrospinal fluid, blood, urine, saliva and skin biopsy
- Brain imaging using Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET)
- Pre-Pulse Inhibition (PPI) (a test to evaluate the startle response)
- Measures of arterial stiffness and amount of vascular narrowing
Participants with psychosis are invited back for repeat measurements at 1,5 and 5 years after study enrollment. Controls may be invited back at 1,5 years for repeat of some of the assessments.
- Keywords
- Psychosis, Psychotic disorders, Schizophrenia
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| First Episode Psychosis (FEP) | Diagnosis of psychotic disorder according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV), where anti-psychotic medication was initiated less than four weeks prior to inclusion. | |
| Healthy Control (HC) | Age and sex matched individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kynurenic acid (KYNA) in FEP compared to HC
KYNA are measured in CSF and blood samples
Measured: Baseline measure
Cytokines in FEP compared to HC
Cytokines are measured in CSF and blood samples
Measured: Baseline measure
Microglial activation in FEP compared to HC
Group comparison of binding of the PET ligand [11C]PBR-28
Measured: Baseline measure
Dopamine receptors in FEP compared to HC
Group comparison of binding of the PET-ligand [11C]FLB457
Measured: Baseline measure
Infectious risk factors in FEP and subsequent relation to clinical outcome
Registry data on previous infections, along with infectious agents measured in CSF and blood. Long term clinical outcome is measured through registry data, by drug-dispensation as well as in-and outpatient care for both somatic and psychiatric disorders.
Measured: Registry data in childhood, measurement at baseline, registry data through study completion (with an expected average of 7 years of follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start25 Jan 2011
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Disorders with Psychotic FeaturesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Carl Sellgren, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872463
- Sponsor's protocol ID
- 2010/879-31/1
- Acronym
- KaSP
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Immunoactivation in Drug-Naive Patients with First Episode Schizophrenia
- ClinicalTrials.gov ID
- NCT06872463
- Acronym / sponsor ID
- KaSP / 2010/879-31/1
- Keywords
- Psychosis, Psychotic disorders, Schizophrenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 25 Jan 2011 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 12 Mar 2025 (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.
KaSP is a multimodal observational study with the goal of clarifying underlying mechanisms that cause psychotic disorders, such as schizophrenia. Participants with psychotic symptoms are recruited early after first contact with health care, within 4 weeks of starting anti-psychotic medication, and are compared to controls without psychiatric diagnoses on several measures.
Detailed description
KaSP aims to recruit 120 patients sparsely medicated or drug-naive first episode psychosis (FEP) individuals, along with 80 healthy controls.
Participants undergo the following assessments and measurements:
- Clinical assessment
- Cognitive testing
- Lab results from cerebrospinal fluid, blood, urine, saliva and skin biopsy
- Brain imaging using Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET)
- Pre-Pulse Inhibition (PPI) (a test to evaluate the startle response)
- Measures of arterial stiffness and amount of vascular narrowing
Participants with psychosis are invited back for repeat measurements at 1,5 and 5 years after study enrollment. Controls may be invited back at 1,5 years for repeat of some of the assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Episode Psychosis (FEP) | – | –Diagnosis of psychotic disorder according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV), where anti-psychotic medication was initiated less than four weeks prior to inclusion. |
| Healthy Control (HC) | – | –Age and sex matched individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- FEP are recruited from psychiatry clinics in the greater Stockholm area. HC are recruited by advertisement.
Key inclusion criteria (3 listed)
- Diagnosis as assessed using DSM-IV of one of the following: schizophrenia, schizophreniform psychosis, psychosis not otherwise specified (NOS), brief psychosis, schizoaffective syndrome, delusional disorder
- First exposure to anti-psychotic medication less than 4 weeks prior to inclusion
Key exclusion criteria (15 listed)
- Other dominant psychiatric illness deemed to be related to current psychotic symptoms
- A history of diagnosis of a major psychiatric disorder, including substance use disorders.
- Family history of psychotic disorders in first degree relatives.
- Evidence based on medical history, clinical signs, MRI or laboratory tests of clinically significant somatic disorder, or previous disorder with brain engagement (e.g. tumour, neuroinflammatory disease, epilepsy) or significant brain trauma.
- Exposure to an effective radiation dose of 25 mSv during the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kynurenic acid (KYNA) in FEP compared to HC
Time frame: Baseline measure
KYNA are measured in CSF and blood samples
Cytokines in FEP compared to HC
Time frame: Baseline measure
Cytokines are measured in CSF and blood samples
Microglial activation in FEP compared to HC
Time frame: Baseline measure
Group comparison of binding of the PET ligand [11C]PBR-28
Dopamine receptors in FEP compared to HC
Time frame: Baseline measure
Group comparison of binding of the PET-ligand [11C]FLB457
Infectious risk factors in FEP and subsequent relation to clinical outcome
Time frame: Registry data in childhood, measurement at baseline, registry data through study completion (with an expected average of 7 years of follow up)
Registry data on previous infections, along with infectious agents measured in CSF and blood. Long term clinical outcome is measured through registry data, by drug-dispensation as well as in-and outpatient care for both somatic and psychiatric disorders.
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 12 Mar 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Schizophrenia and Disorders with Psychotic Features
RecruitingPhase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Recruiting
Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Schizophrenia, Cerebellar Function
Recruiting
tACS for Working Memory in Schizophrenia
Schizophrenia, Working Memory
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Disorders with Psychotic Features, run by Karolinska Institutet at 1 site in Sweden.
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 15 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 12 Mar 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 Sweden. 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?
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 Carl M Sellgren, MD, PhD (+46 702127287, carl.sellgren@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kynurenic acid (KYNA) in FEP compared to HC (time frame: Baseline measure). The study lists 5 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 12 Mar 2025.