Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Inclusion Criteria

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 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 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.
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 Criteria

Unwillingness or inability of subject to undergo PET and/or MRI scan (for example due to claustrophobia or lack of cooperation)
Worsening or first time occurrence of significant suicidality
Use of systemic corticosteroids within 21 days of screening.
...
Unwillingness or inability of subject to undergo PET and/or MRI scan (for example due to claustrophobia or lack of cooperation)
Worsening or first time occurrence of significant suicidality
Use of systemic corticosteroids within 21 days of screening.
Female subjects only: is pregnant or breastfeeding
Has a medical history of traumatic brain injury
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.
Has a medical history of any auto-immune disorder or chronic inflammatory disease.
Has received electroconvulsive therapy in the last 6 months.
Leukocytosis (i.e., white blood cell count ≤ 11 x109 /L) on screening and test days.
Has a positive test result for drugs of abuse or for alcohol at screening or test day.
Has a history of chronic or acute physical illness associated with abnormal immune changes within the 2 weeks before the study.
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.
Low affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at Screening
Is currently enrolled in a study with an investigational study drug.
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 allergic reaction to any of the substances in the tracer fluid.
Use of nonsteroidal antiinflammatory drugs, paracetamol, immunosuppressant or immunostimulating drugs within 21 days of screening.
Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV antibodies at screening.
Has a medical history of organic brain disease
Has donated blood within 3 months before 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 Criteria

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 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 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.
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 Criteria

Unwillingness or inability of subject to undergo PET and/or MRI scan (for example due to claustrophobia or lack of cooperation)
Worsening or first time occurrence of significant suicidality
Use of systemic corticosteroids within 21 days of screening.
...
Unwillingness or inability of subject to undergo PET and/or MRI scan (for example due to claustrophobia or lack of cooperation)
Worsening or first time occurrence of significant suicidality
Use of systemic corticosteroids within 21 days of screening.
Female subjects only: is pregnant or breastfeeding
Has a medical history of traumatic brain injury
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.
Has a medical history of any auto-immune disorder or chronic inflammatory disease.
Has received electroconvulsive therapy in the last 6 months.
Leukocytosis (i.e., white blood cell count ≤ 11 x109 /L) on screening and test days.
Has a positive test result for drugs of abuse or for alcohol at screening or test day.
Has a history of chronic or acute physical illness associated with abnormal immune changes within the 2 weeks before the study.
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.
Low affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at Screening
Is currently enrolled in a study with an investigational study drug.
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 allergic reaction to any of the substances in the tracer fluid.
Use of nonsteroidal antiinflammatory drugs, paracetamol, immunosuppressant or immunostimulating drugs within 21 days of screening.
Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV antibodies at screening.
Has a medical history of organic brain disease
Has donated blood within 3 months before screening.

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
About Us
Innovation
Privacy
Terms
Copyright
Get Well Soon © Copyright 2024