SchizophreniaPANSNCT02009826
Psychosis-Associated Neuroinflammation in Schizophrenia
An observational study of Schizophrenia and Psychosis, run by Universiteit Antwerpen at 3 sites in Belgium.
Trial summary
Previous research has suggested central nervous system inflammatory activity to be critically involved in disease development and progression in schizophrenia, with a complex interplay of inflammatory mechanisms leading to the development of brain abnormalities and medical symptoms related to schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychosis
- What is being tested?
- [18F]-PBR111 Positron Emission Tomography (PET), Cognitive and psychomotor tasks and Blood sampling
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 106 participants
- Where
- 3 sitesBelgium
- Study dates
- Nov 2013to Feb 2017
- Phase
- Observational
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young schizophrenia patients admitted to psychiatric hospital for acute relapse or first-episode of psychosis
Who may be able to join
- Be a man or woman between 18 and 40 years of age, inclusive.
- Have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in this study.
- Be medically stable on the basis of physical examination and vital signs performed at Screening.
- Be medically stable on the basis of clinical laboratory tests performed at Screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study.
- Be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
- Schizophrenia subjects:
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- Fulfill DSM-V criteria for the schizophrenia spectrum (DSM-V #295.1-295.6, 295.9, 298.9)
- Be admitted to hospital for first-episode psychosis or acute relapse of psychosis, as defined by:
- total score of ≥14 on the positive scale of the "Positive and Negative Syndrome Scale" (PANSS) and at least a score of 5 on 1 item or a score of 4 on 2 "psychotic" PANSS items P2, P3, P5 or G9 at Screening.
Who cannot join
- Use of nonsteroidal antiinflammatory drugs, paracetamol, immunosuppressant or immunostimulating drugs within 21 days of screening.
- Use of systemic corticosteroids within 21 days of screening.
- Has a history of drug or alcohol dependence according to DSM-V criteria, except nicotine or caffeine, within 6 months before screening.
- Has history of (co-morbid) somatization or mood disorder according to DSM-V criteria within 6 months before screening.
- Has a positive test result for drugs of abuse or for alcohol at screening or test day.
- Female subjects only: is pregnant or breastfeeding
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- Has a history of chronic or acute physical illness associated with abnormal immune changes within the 2 weeks before the study.
- Leukocytosis (i.e., white blood cell count ≤ 11 x109 /L) on screening and test days.
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV antibodies at screening.
- Has a medical history of any auto-immune disorder or chronic inflammatory disease.
- Has received electroconvulsive therapy in the last 6 months.
- Is currently enrolled in a study with an investigational study drug.
- Worsening or first time occurrence of significant suicidality
- Has donated blood within 3 months before screening.
- Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements.
- Low affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at Screening
- Use of benzodiazepines for 3x the half-life prior to PET-scan
- Presence of irremovable magnetic materials in or on the body
- Has a medical history of organic brain disease
- Has a medical history of traumatic brain injury
- Has a medical history of allergic reaction to any of the substances in the tracer fluid.
- Unwillingness or inability of subject to undergo PET and/or MRI scan (for example due to claustrophobia or lack of cooperation)
- Healthy volunteers:
- Personal history of psychotic disorder
- Family history of psychotic or bipolar disorder in first-degree relatives
- Family history of auto-immune disorder in first-degree relatives
- Schizophrenia patients:
- Calgary Depression Scale for Schizophrenia (CDSS) score >6 at screening
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Psychiatrisch Ziekenhuis Broeders Alexianen
Boechout, Antwerpen, 2530
Psychiatrisch Ziekenhuis St Norbertus
Duffel, Antwerpen, 2570
Psychiatrisch Ziekenhuis Sint-Amedeus
Mortsel, Antwerp, 2640
About this study
Official title: Phase 0 Clinical Protocol: A Longitudinal and Multimodal Exploratory Study to Evaluate a Neuroinflammatory Hypothesis in Patients With Schizophrenia Compared to Young Healthy Subjects
Previous research has suggested central nervous system inflammatory activity to be critically involved in disease development and progression in schizophrenia, with a complex interplay of inflammatory mechanisms leading to the development of brain abnormalities and medical symptoms related to schizophrenia. However, the mutual interactions of different inflammatory pathways and their relation to disease course have not been sufficiently studied. This study therefore aims to explore the interaction of neuroinflammatory mechanisms in patients with schizophrenia and to assess whether the inflammatory activity in schizophrenia is state-dependent and occurs mainly during psychotic episodes.
- Conditions
- Schizophrenia, Psychosis
- Being tested
- [18F]-PBR111 Positron Emission Tomography (PET), Cognitive and psychomotor tasks, Blood sampling
- Keywords
- Schizophrenia, Psychosis, Neuroinflammation, Microglial activation
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-PBR111 Positron Emission Tomography (PET)Radiation
[18F]-PBR111 radioligand to assess binding to TSPO
Cognitive and psychomotor tasksBehavioural
Cognitive and psychomotor tasks on digitizing tablet
Blood samplingBiological
Blood sampling for peripheral inflammatory and neurotoxicity markers
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Healthy age- and sex-matched controls Receives: Radiation: [18F]-PBR111 Positron Emission Tomography (PET); Behavioral: Cognitive and psychomotor tasks; Biological: Blood sampling | |
| Schizophrenia patients | Young schizophrenia patients 18-40y Receives: Radiation: [18F]-PBR111 Positron Emission Tomography (PET); Behavioral: Cognitive and psychomotor tasks; Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional VT of [18F]PBR111
Regional distribution volume in tissue (VT) of 2-(6-chloro-2-(4-(3-fluoropropoxy)phenyl)imidazo(1,2-a)pyridin-3-yl)-N,N-diethylacetamide (PBR111) labelled with fluorine-18 (18F) in schizophrenia patients and age- , gender-, and translocator protein (TSPO) binding profile- matched healthy controls
Measured: 2 years
Secondary outcomes (1)
Peripheral markers
Levels and ratios of inflammatory and neurotoxicity markers in blood samples of schizophrenia patients compared to healthy age- and gender-matched healthy controls.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie, Janssen Research & Development, LLC
- Responsible party
- Principal investigator, Dr Livia De Picker, Universiteit Antwerpen
- Investigators
- Bernard Sabbe, MD PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009826
- Sponsor's protocol ID
- CAPRI13/37/348
- Other IDs
- B300201318710
- Acronym
- PANS
- Status last verified
- Aug 2017
- First submitted
- 9 Dec 2013
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 Clinical Protocol: A Longitudinal and Multimodal Exploratory Study to Evaluate a Neuroinflammatory Hypothesis in Patients With Schizophrenia Compared to Young Healthy Subjects
- ClinicalTrials.gov ID
- NCT02009826
- Acronym / sponsor ID
- PANS / CAPRI13/37/348
- Conditions
- Schizophrenia, Psychosis
- Keywords
- Schizophrenia, Psychosis, Neuroinflammation, Microglial activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie, Janssen Research & Development, LLC
- Study start
- Nov 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 12 Dec 2013 (estimated)
- 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.
Previous research has suggested central nervous system inflammatory activity to be critically involved in disease development and progression in schizophrenia, with a complex interplay of inflammatory mechanisms leading to the development of brain abnormalities and medical symptoms related to schizophrenia. However, the mutual interactions of different inflammatory pathways and their relation to disease course have not been sufficiently studied. This study therefore aims to explore the interaction of neuroinflammatory mechanisms in patients with schizophrenia and to assess whether the inflammatory activity in schizophrenia is state-dependent and occurs mainly during psychotic episodes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Radiation: [18F]-PBR111 Positron Emission Tomography (PET), Behavioral: Cognitive and psychomotor tasks, Biological: Blood samplingHealthy age- and sex-matched controls |
| Schizophrenia patients | – | Radiation: [18F]-PBR111 Positron Emission Tomography (PET), Behavioral: Cognitive and psychomotor tasks, Biological: Blood samplingYoung schizophrenia patients 18-40y |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young schizophrenia patients admitted to psychiatric hospital for acute relapse or first-episode of psychosis
Key inclusion criteria (9 listed)
- Be a man or woman between 18 and 40 years of age, inclusive.
- Have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in this study.
- Be medically stable on the basis of physical examination and vital signs performed at Screening.
- Be medically stable on the basis of clinical laboratory tests performed at Screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study.
- Be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
Key exclusion criteria (28 listed)
- Use of nonsteroidal antiinflammatory drugs, paracetamol, immunosuppressant or immunostimulating drugs within 21 days of screening.
- Use of systemic corticosteroids within 21 days of screening.
- Has a history of drug or alcohol dependence according to DSM-V criteria, except nicotine or caffeine, within 6 months before screening.
- Has history of (co-morbid) somatization or mood disorder according to DSM-V criteria within 6 months before screening.
- Has a positive test result for drugs of abuse or for alcohol at screening or test day.
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 |
|---|---|---|
| [18F]-PBR111 Positron Emission Tomography (PET)[18F]-PBR111 radioligand to assess binding to TSPO | Radiation | Healthy controls, Schizophrenia patients |
| Cognitive and psychomotor tasksCognitive and psychomotor tasks on digitizing tablet | Behavioural | Healthy controls, Schizophrenia patients |
| Blood samplingBlood sampling for peripheral inflammatory and neurotoxicity markers | Biological | Healthy controls, Schizophrenia patients |
Primary outcome
Regional VT of [18F]PBR111
Time frame: 2 years
Regional distribution volume in tissue (VT) of 2-(6-chloro-2-(4-(3-fluoropropoxy)phenyl)imidazo(1,2-a)pyridin-3-yl)-N,N-diethylacetamide (PBR111) labelled with fluorine-18 (18F) in schizophrenia patients and age- , gender-, and translocator protein (TSPO) binding profile- matched healthy controls
1 secondary outcome
Peripheral markers
Time frame: 2 years
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 31 Aug 2017.
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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.
Bernard Sabbe, MD PhD principal investigator
Universiteit Antwerpen
3 sites 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 Psychosis, run by Universiteit Antwerpen at 3 sites in Belgium.
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 9 inclusion and 28 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 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
Regional VT of [18F]PBR111 (time frame: 2 years). 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 31 Aug 2017.