NCT02009826

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

December 9, 2013

Last Update Submit

August 30, 2017

Conditions

SchizophreniaPsychosis

Keywords

SchizophreniaPsychosisNeuroinflammationMicroglial activation

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (1)

  • Peripheral markers

    2 years

Study Arms (2)

Healthy controls

Healthy age- and sex-matched controls

Radiation: [18F]-PBR111 Positron Emission Tomography (PET)Behavioral: Cognitive and psychomotor tasksBiological: Blood sampling

Schizophrenia patients

Young schizophrenia patients 18-40y

Radiation: [18F]-PBR111 Positron Emission Tomography (PET)Behavioral: Cognitive and psychomotor tasksBiological: Blood sampling

Interventions

[18F]-PBR111 Positron Emission Tomography (PET)RADIATION

\[18F\]-PBR111 radioligand to assess binding to TSPO

Healthy controlsSchizophrenia patients
Cognitive and psychomotor tasksBEHAVIORAL

Cognitive and psychomotor tasks on digitizing tablet

Healthy controlsSchizophrenia patients
Blood samplingBIOLOGICAL

Blood sampling for peripheral inflammatory and neurotoxicity markers

Healthy controlsSchizophrenia patients

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young schizophrenia patients admitted to psychiatric hospital for acute relapse or first-episode of psychosis

You may qualify if:

  • 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:
  • 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.

You may not qualify if:

  • 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
  • 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.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Psychiatrisch Ziekenhuis Broeders Alexianen

Boechout, Antwerpen, 2530, Belgium

Location

Psychiatrisch Ziekenhuis St Norbertus

Duffel, Antwerpen, 2570, Belgium

Location

Psychiatrisch Ziekenhuis Sint-Amedeus

Mortsel, Antwerp, 2640, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersNeuroinflammatory Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNervous System DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Bernard Sabbe, MD PhD

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

August 31, 2017

Record last verified: 2017-08

Locations

BE(3)