Clinical trial NCT01577160: A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
Official title: An Open Label, Prospective, Non-Comparative Study to Evaluate Flexible Dose of Paliperidone ER and Clinical Response in the Treatment of Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone Extended Release (ER)
Lead sponsor: Johnson & Johnson Taiwan Ltd
Sponsor class: INDUSTRY
First posted: 2012-04-13
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 of paliperidone ER for the treatment of 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 a multi-center (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), prospective (study following participants forward in time), non-comparative study. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 2, 4, 8, and 12 (end of treatment or early withdrawal). The effectiveness of paliperidone ER will be evaluated at Week 12 by the proportion of responders who are evaluated as "very much improved" or "much improved" on the Clinical Global Impression improvement (CGI-I) Scale. Participants' safety will also be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants who are diagnosed with schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders \[Edition 4\] criteria)
* Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
* Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
* Participants who are capable of and willing to fill out the questionnaire for themselves
* Participants who are compliant with self-medication or can receive consistent help or support

Exclusion Criteria:

* Participants with the past 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)
* Participants with allergy or hypersensitivity to risperidone or paliperidone
* Participants who have taken clozapine, or have been exposed to the study drug within one month before screening
* Participants who have been treated with the long acting antipsychotic injection within 28 days
* Participants with significant risk including suicide or aggressive behavior

Primary outcomes:
measure: Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
timeFrame: Week 12
measure: Change From Baseline in Personal and Social Performance (PSP) Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Taiwan Ltd
name: Johnson & Johnson Taiwan Ltd Clinical Trial
role: STUDY_DIRECTOR
References: