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 | Terminated Phase 4 Results

• 1 other identifier: CR015277
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Schizophrenia

Keywords

D2-receptor occupancy; Antipsychotic drugs; Paliperidone ER, Oral risperidone; Dopamine; Fallypride; Plasma concentration; Therapeutic window, Healthy controls

Outcome Measures

Primary Outcomes (1)

• Percentage of Paliperidone or Risperidone Dopamine D2 Receptor Occupancies

  Visit 3 (on day 3)

Secondary Outcomes (2)

• Plasma Concentrations of Paliperidone and Risperidone

  Measurement of plasma concentration at Visit 3 (day 3)

• Assessment of the Ratio of Dopamine D2-receptor Occupancies in Two Different Areas of the Brain

  Analysis of PET scans at Visit 3 (day 3)

Study Arms (9)

002

ACTIVE COMPARATOR

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

Drug: Paliperidone ER

003

ACTIVE COMPARATOR

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

Drug: Oral risperidone

004

ACTIVE COMPARATOR

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

Drug: Oral risperidone

005

ACTIVE COMPARATOR

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

Drug: Paliperidone ER

006

ACTIVE COMPARATOR

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

Drug: Paliperidone ER

007

ACTIVE COMPARATOR

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

Drug: Oral risperidone

008

ACTIVE COMPARATOR

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

Drug: Oral risperidone

009

OTHER

PET Scan PET Scan

Other: PET Scan

001

ACTIVE COMPARATOR

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

Drug: Paliperidone ER

Interventions

Paliperidone ER DRUG

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

002

Oral risperidone DRUG

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

004

PET Scan OTHER

PET Scan

009

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
• Patients with a specified severity of the disease (Clinical Global Impression Scale of Severity (CGI-S) range of \> 2 \< 5)
• Patients must be on antipsychotic medication with either paliperidone ER or oral risperidone in monotherapy for at least two weeks and must be at least five days on a stable dose of either paliperidone ER 6 mg or 9 mg or oral risperidone 4 mg or 6 mg once daily
• Female patients of childbearing potential must have a negative human chorionic gonadotropin urine pregnancy test (ß-HCG) at visit 1 or must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry, throughout the study and at least one month after study end
• Healthy control volunteers must be off all standard prescription drug therapy, over the counter compounds (OTC) and recreational substances/drugs for at least one week prior to participation in the study
• Female volunteers of childbearing potential must have a negative ß -HCG pregnancy test at visit 1 or be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry, throughout the study and at least one month after the study end
• Patients and volunteers must be able to read, understand and sign the Institutional Review Board approved informed consent form

You may not qualify if:

• Patients: Any depot neuroleptic medication (long acting injectables) in the last three months
• Any antipsychotic compound, antidepressant, antiepileptic ("mood stabilizers"), lithium, anticholinergic within 2 weeks prior to study
• Any psychopharmacologically active medication (except benzodiazepines, paracetamol and zopiclone as rescue medication) taken within the trial
• Physical and psychological conditions that interfere with the study procedures, or could influence the study results, or could endanger the patient during the study
• Alcohol and/or drug abuse four weeks prior to study start (patients with alcohol or drug abuse as defined by the DSM-IV criteria can participate if free of their of abuse for at least four weeks)
• Clinically relevant laboratory abnormality
• Pregnant or breast feeding patients

Sponsors & Collaborators

• Janssen-Cilag G.m.b.H: lead

Study Sites (1)

Unknown Facility

Aachen, Germany

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate; Risperidone; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pyrimidinones; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Two subjects enrolled, both completed study per protocol. Study was prematurely terminated, data obtained were not submitted to further statistical analysis and will not be applicable for scientific analysis due to the low number of subjects.

Results Point of Contact

• Title: Medical Development Manager; Medical and Scientific Affairs
• Organization: Janssen Cilag

0049-2137-955-1240

Study Officials

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

  Janssen-Cilag G.m.b.H

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 11, 2014
• Results First Posted: January 11, 2011

Record last verified: 2014-01

Locations

DE (1)