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 Patient

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen-Cilag G.m.b.H
• Treatments: Antipsychotic Agents; Dopamine; Paliperidone Palmitate; Risperidone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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