Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Inclusion Criterias

Be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
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 a man or woman between 18 and 40 years of age, inclusive.
...
Be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
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 a man or woman between 18 and 40 years of age, inclusive.
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.

Exclusion Criterias

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)
Has donated blood within 3 months before screening.
...
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)
Has donated blood within 3 months before screening.
Is currently enrolled in a study with an investigational study drug.
Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV antibodies at 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.
Worsening or first time occurrence of significant suicidality
Has history of (co-morbid) somatization or mood disorder according to DSM-V criteria within 6 months before screening.
Has a medical history of any auto-immune disorder or chronic inflammatory disease.
Low affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at 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
Presence of irremovable magnetic materials in or on the body
Has a history of drug or alcohol dependence according to DSM-V criteria, except nicotine or caffeine, within 6 months before screening.
Has received electroconvulsive therapy in the last 6 months.
Use of systemic corticosteroids within 21 days of screening.
Has a medical history of traumatic brain injury
Has a medical history of organic brain disease
Leukocytosis (i.e., white blood cell count ≤ 11 x109 /L) on screening and test days.
Has a history of chronic or acute physical illness associated with abnormal immune changes within the 2 weeks before the study.
Use of benzodiazepines for 3x the half-life prior to PET-scan
Use of nonsteroidal antiinflammatory drugs, paracetamol, immunosuppressant or immunostimulating drugs within 21 days of screening.

Summary

Conditions
  • Psychosis
  • Schizophrenia
Type
Observational
Design
  • Observational Model: Case-Control
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 40 years
Gender
Both males and females

Inclusion Criterias

Be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
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 a man or woman between 18 and 40 years of age, inclusive.
...
Be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
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 a man or woman between 18 and 40 years of age, inclusive.
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.

Exclusion Criterias

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)
Has donated blood within 3 months before screening.
...
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)
Has donated blood within 3 months before screening.
Is currently enrolled in a study with an investigational study drug.
Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV antibodies at 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.
Worsening or first time occurrence of significant suicidality
Has history of (co-morbid) somatization or mood disorder according to DSM-V criteria within 6 months before screening.
Has a medical history of any auto-immune disorder or chronic inflammatory disease.
Low affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at 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
Presence of irremovable magnetic materials in or on the body
Has a history of drug or alcohol dependence according to DSM-V criteria, except nicotine or caffeine, within 6 months before screening.
Has received electroconvulsive therapy in the last 6 months.
Use of systemic corticosteroids within 21 days of screening.
Has a medical history of traumatic brain injury
Has a medical history of organic brain disease
Leukocytosis (i.e., white blood cell count ≤ 11 x109 /L) on screening and test days.
Has a history of chronic or acute physical illness associated with abnormal immune changes within the 2 weeks before the study.
Use of benzodiazepines for 3x the half-life prior to PET-scan
Use of nonsteroidal antiinflammatory drugs, paracetamol, immunosuppressant or immunostimulating drugs within 21 days of screening.

Locations

Boechout, Antwerpen, 2530
Mortsel, Antwerp, 2640
Duffel, Antwerpen, 2570
Boechout, Antwerpen, 2530
Mortsel, Antwerp, 2640
Duffel, Antwerpen, 2570

Tracking Information

NCT #
NCT02009826
Collaborators
  • Agentschap voor Innovatie door Wetenschap en Technologie
  • Janssen Research & Development, LLC
Investigators
  • Principal Investigator: Bernard Sabbe, MD PhD Universiteit Antwerpen
  • Bernard Sabbe, MD PhD Universiteit Antwerpen