A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Paliperidone palmitate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01606254

CR013612

PALM-JPN-2 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Full description

This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), parallel-group (Each group of participants will be treated at the same time), comparison study to assess the pharmacokinetics and safety of paliperidone palmitate (study medication) in participants with schizophrenia. The study comprises a 64-day Treatment period and a 155-day Follow-up period. The participants will be randomly assigned to one of the four study groups. The study medication will be administered on Days 1, 8, 36 and 64. Pharmacokinetics of the study medication will be assessed as primary outcome. Participants' safety will be monitored throughout the study.

Enrollment: 56 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Participants who have been diagnosed with schizophrenia in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)
• Participants may be inpatients or outpatients
• Participants who have been taking an oral antipsychotic medication for at least 28 days before the date of informed consent
• Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than or equal to 4 (moderate) at screening
• Participants who have taken risperidone by the start of investigational treatment and the record can be confirmed Exclusion Criteria
• Participants who have been diagnosed with a mental disease other than schizophrenia in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)
• Participants who have been diagnosed with substance-related disorders (except nicotine and caffeine dependence)
• Participants with complicated parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is muscle weakness, trembling and sweating)
• Participants with a complication of or with a history of convulsive disease such as epilepsy (seizure disorder)
• Participants with a complication of or with a history of cerebro-vascular accident (stroke), neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) or physical exhaustion associated with the state of dehydration (lose of water and minerals in the body) or malnutrition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 4 patient groups

Paliperidone palmitate 50 mg

Experimental group

Description:

Paliperidone palmitate 50 milligram (mg) intramuscular (into the muscle) injection on Days 1, 8, 36 and 64.

Treatment:

Drug: Paliperidone palmitate

Paliperidone palmitate 100 mg

Experimental group

Description:

Paliperidone palmitate 100 mg intramuscular injection on Days 1, 8, 36 and 64.

Treatment:

Drug: Paliperidone palmitate

Paliperidone palmitate 150 mg

Experimental group

Description:

Paliperidone palmitate 150 mg intramuscular injection on Days 1, 8, 36 and 64.

Treatment:

Drug: Paliperidone palmitate

Paliperidone palmitate 150/ 50 mg

Experimental group

Description:

Paliperidone palmitate 150 mg intramuscular injection on Day 1 and paliperidone palmitate 50 mg intramuscular injection on Days 8, 36 and 64.

Treatment:

Drug: Paliperidone palmitate