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A Positron-Emission-Tomography (PET) Study to Measure the Blockade of Dopamine Receptors (D2) in Specific Areas of the Brain in Relation to the Plasma Concentrations of Paliperidone Extended Release (ER) and Oral Risperidone in Schizophrenia Patients and Healthy Controls

NCT00934635 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2014-02-11

Study results available
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Summary

The primary objective of this study is to compare the effect of two different antipsychotic compounds which are used in the treatment of schizophrenia (paliperidone ER and risperidone) at their target sites in two specific areas of the brain in patients with schizophrenia. A specialized X-ray known as Positron Emission Tomography (PET) Imaging is used to assess the areas of the brain targeted by both compounds.

Conditions

Interventions

DRUG

Paliperidone ER

9 mg tablet once a day followed by PET scan in approximately 2 hours

DRUG

Oral risperidone

6 mg tablet once a day followed by PET scan in approximately 2 hours

OTHER

PET Scan

PET Scan

DRUG

Oral risperidone

4 mg tablet once a day followed by PET scan in approximately 24 hours

DRUG

Oral risperidone

4 mg tablet once a day followed by PET scan in approximately 2 hours

DRUG

Paliperidone ER

6 mg tablet once a day followed by PET scan in approximately 2 hours

DRUG

Paliperidone ER

6 mg tablet once a day followed by PET scan in approximately 24 hours

DRUG

Oral risperidone

6 mg tablet once a day followed by PET scan in approximately 24 hours

DRUG

Paliperidone ER

9 mg tablet once a day followed by PET scan in approximately 24 hours

Sponsors & Collaborators

  • Janssen-Cilag G.m.b.H

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag G.m.b.H. Clinical Trial · Janssen-Cilag G.m.b.H

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00934635 on ClinicalTrials.gov