Clinical trial NCT01387542: Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants
Official title: An Open-label, PRospective Study to Evaluate Social Function and Overall Improvement of Paliperidone ER Treatment in Thai Schizophrenia PatieNT (PRESENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone Extended Release (ER)
INVEGA
Lead sponsor: Janssen-Cilag Ltd.,Thailand
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) treatment in Thai schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.

Detailed description: This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance) study to evaluate the efficacy and safety of paliperidone ER in adult Thai schizophrenia participants. The study consists of a screening phase and an open-label treatment phase. Study duration will be 10 weeks and participants can either be inpatient or outpatient. The recommended paliperidone ER starting and maintenance dose will be 6 milligram (mg) per day for most participants. Throughout the study, flexible dosing ranging from 3 to 12 mg per day may be used at the discretion of the investigator. Throughout the study, participants will be evaluated for efficacy using clinician rating (Clinical and Global Impressions-Severity \[CGI-S\] scale, and Personal and Social Performance Scale \[PSP\]) scales. Safety of the participants will be monitored.

Eligibility criteria: Inclusion Criteria:

* Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
* Participants unsatisfied with their previous treatment
* Previously or currently on oral atypical antipsychotics

Exclusion Criteria:

* Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
* History or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
* History of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
* Pregnant or breast-feeding female
* Participation in an investigational drug trial within 30 days prior to selection

Primary outcomes:
measure: Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10
timeFrame: Baseline, Week 10
measure: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10
timeFrame: Baseline, Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
city: Songkhla
country: Thailand
Study officials:
affiliation: Janssen-Cilag Ltd.,Thailand
name: Janssen-Cilag Ltd.,Thailand Clinical Trial
role: STUDY_DIRECTOR
References: