Clinical trial NCT01606254: A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia
Official title: A Repeated Dose Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone Palmitate
JNS010
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2012-05-25
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8
timeFrame: Day 8
measure: Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36
timeFrame: Day 36
measure: Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64
timeFrame: Day 64
measure: Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92
timeFrame: Day 92
measure: Maximum Observed Plasma Concentration (Cmax) of Paliperidone
timeFrame: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone
timeFrame: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
timeFrame: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
measure: Plasma Paliperidone Concentration at Steady State (Css av)
timeFrame: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
measure: Paliperidone Plasma Decay Half-Life (t1/2)
timeFrame: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
measure: Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8
timeFrame: Day 8
measure: Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22
timeFrame: Day 22
measure: Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50
timeFrame: Day 50
measure: Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78
timeFrame: Day 78
measure: Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92
timeFrame: Day 92
measure: Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120
timeFrame: Day 120
measure: Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162
timeFrame: Day 162
measure: Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218
timeFrame: Day 218
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline, Day 8, 22, 50, 78 and 92
measure: Number of Participants With Clinical Global Impression Severity (CGI-S) Score
timeFrame: Baseline, Day 8, 22, 50, 78 and 92
Other outcomes:
Locations:
city: Ichikawa
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: