The therapeutic window” of the atypical” antipsychotic paliperidone ER - A Positron Emission Tomography study with [18F]fallypride as the radiotracer

• Conditions: subchronic schizophrenia; MedDRA version: 8.1Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2008-003340-11-DE
• Lead Sponsor: JANSSEN-CILAG GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-19
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients:
1. Schizophrenia meeting DSM-IV criteria;
2. Male or female, aged 18-50 years;
3. CGI-S range between 2 or more and 5 or less;
4. At least 2 weeks antipsychotic medication with paliperidone ER or oral
risperidone in monotherapy and at least 5 days stable dose of paliperidone or
risperidone (application of medication should be carried out according the SmPC under consideration of contraindications, warning notices and interactions);
5. Ability to read, understand and sign the informed consent form;
6. Female subjects must be postmenopausal for at least 1 year, surgically sterile,
abstinent, or, if sexually active, agree to practice an effective hormonal method of
birth control before entry, throughout the study and at least 1 month after the in-
dividual study end. Female subjects of childbearing potential must have a
negative ßHCG-pregnancy test at visit 1.
Healthy control subjects:
- meet points 2, 5 and 6;
- are off all standard prescription drug therapy, OTC or recreational drugs for at least
one week prior to participation in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient:
1. has taken depot neuroleptic medication for at least 3 months prior to the start
of the study;
2. has taken another oral antipsychotic compound, antidepressant, anticonvulsant
(mood stabilizer) for at least 2 weeks prior to the start of the study;
3. is taking any other centrally active medication (except benzodiazepines,
paracetamole and zopiclone as rescue medication) within the trial;
4. has physical and psychological conditions that
odo interfere with the study procedures;
ocould influence the study results;
ocould endanger the subject during the study.
5. has a clinically relevant abnormality in clinical chemistry and hematology;
6. has a history or current symptoms of tardive dyskinesia;
7. has a history of neuroleptic malignant syndrome;
8. is suicidal or have a potential danger for third parties, judged to be at high risk
for adverse events, violence, or self-harm;
9. is pregnant or breast-feeding;
10. participates in a parallely conducted interventional study or has been
participating in an investigational study within 3 months prior to enrolment;
11. has a known hypersensitivity to paliperidone or risperidone;
12. has been abusing alcohol and/or drugs for at least four weeks prior to study
start;
13. is inable to sign the Institutional Review Board-approved informed consent
form (ICF) due to the psychopathological condition;
14. is an employee of the investigator or study site, person with direct involvement
in the proposed study or other studies under the direction of that investigator or
study site, family member of the investigator or family member of the
employees of the investigator.
15. has anot drug related hyperprolactinaemia
16. is staying in a psychiatric clinic due to judicial order or order of a medical
attendant.
Healthy control subject:
see points 4, 5, 9, 10, 12, 13 and 14.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of the striatal and extrastriatal D2 receptor occupancies at time of peak and trough plasma concentrations in subchronic schizophrenic patients under stable treatment with either 6 mg or 9 mg paliperidone ER once daily and subjects under stable treatment with either 4 mg or 6 mg oral risperidone once daily as well as healthy controls. ;Secondary Objective: Evaluation of mesolimbic selectivity for both compounds and both treatment regimens by measurements of striatal and extrastriatal regional D2 occupancies.;Primary end point(s): Therapeutical D2 receptor occupancies (PET imaging of radio-tracer fallypride) at time of peak to trough plasma concentrations in subchronic schizophrenic patients treated with 6 mg or 9 mg paliperidone ER once daily and subjects treated with 4 mg or 6 mg oral risperidone once daily as well as healthy controls.