NCT06872463Recruiting
Karolinska Schizophrenia Project
Brain Immunoactivation in Drug-Naive Patients with First Episode Schizophrenia
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 3 Mar 2025
- Start date
- 25 Jan 2011
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Karolinska Institutet
- Diseases
- Schizophrenia
- NCT number
- NCT06872463
What you commit to
- Study type: Observational
- Planned participants: 200
- From 25 Jan 2011 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exposure to an effective radiation dose of 25 mSv during the past year.
- 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.
Other illness
- \- 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.
- For all:
- 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.
Lab values
- 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.
- 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
- For FEP:
- For HC:
- Pregnancy, lactating or breastfeeding (women).
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SLSO Psykiatri Stockholm in collaboration w Karolinska Institutet Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.