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Trial record 30 of 3313 for:    schizophrenia

Psychosis-Associated Neuroinflammation in Schizophrenia (PANS)

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ClinicalTrials.gov Identifier: NCT02009826
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : August 31, 2017
Sponsor:
Collaborators:
Agentschap voor Innovatie door Wetenschap en Technologie
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Dr Livia De Picker, Universiteit Antwerpen

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.

Condition or disease Intervention/treatment
Schizophrenia Psychosis Radiation: [18F]-PBR111 Positron Emission Tomography (PET) Behavioral: Cognitive and psychomotor tasks Biological: Blood sampling

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Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Study Start Date : November 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy controls
Healthy age- and sex-matched controls
Radiation: [18F]-PBR111 Positron Emission Tomography (PET)
[18F]-PBR111 radioligand to assess binding to TSPO

Behavioral: Cognitive and psychomotor tasks
Cognitive and psychomotor tasks on digitizing tablet

Biological: Blood sampling
Blood sampling for peripheral inflammatory and neurotoxicity markers

Schizophrenia patients
Young schizophrenia patients 18-40y
Radiation: [18F]-PBR111 Positron Emission Tomography (PET)
[18F]-PBR111 radioligand to assess binding to TSPO

Behavioral: Cognitive and psychomotor tasks
Cognitive and psychomotor tasks on digitizing tablet

Biological: Blood sampling
Blood sampling for peripheral inflammatory and neurotoxicity markers




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Peripheral markers [ Time Frame: 2 years ]
    Levels and ratios of inflammatory and neurotoxicity markers in blood samples of schizophrenia patients compared to healthy age- and gender-matched healthy controls.


Biospecimen Retention:   Samples Without DNA
Plasma samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young schizophrenia patients admitted to psychiatric hospital for acute relapse or first-episode of psychosis
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009826


Locations
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Belgium
Psychiatrisch Ziekenhuis Broeders Alexianen
Boechout, Antwerpen, Belgium, 2530
Psychiatrisch Ziekenhuis St Norbertus
Duffel, Antwerpen, Belgium, 2570
Psychiatrisch Ziekenhuis Sint-Amedeus
Mortsel, Antwerp, Belgium, 2640
Sponsors and Collaborators
Universiteit Antwerpen
Agentschap voor Innovatie door Wetenschap en Technologie
Janssen Research & Development, LLC
Investigators
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Principal Investigator: Bernard Sabbe, MD PhD Universiteit Antwerpen

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Responsible Party: Dr Livia De Picker, Medical Doctor, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT02009826     History of Changes
Other Study ID Numbers: CAPRI13/37/348
B300201318710 ( Other Identifier: Belgian Study Registration Number )
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Keywords provided by Dr Livia De Picker, Universiteit Antwerpen:
Schizophrenia
Psychosis
Neuroinflammation
Microglial activation
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders