Clinical trial NCT01606228: A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia
Official title: An Open-Label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly-Dosed Paliperidone ER Among Treatment-Naïve and Newly Diagnosed Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone ER
Treatment naive patients
Newly diagnosed patients
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2012-05-25
Enrollment: 188
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 explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.

Detailed description: This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with schizophrenia
* Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening
* Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
* Patient healthy on the basis of a physical examination, laboratory examination, and vital signs
* Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study

Exclusion Criteria:

* Serious unstable medical condition, including known clinically relevant laboratory abnormalities
* Judged to be at high risk for adverse events, violence or self-harm
* Inability to swallow the study medication whole with the aid of water (patients may not chew, divide, dissolve, or crush the study medication)
* Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
* Patients with a current use or known history (over the past 6 months) of substance dependence
* Positive urine drug examination

Primary outcomes:
measure: The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)
timeFrame: Baseline, Day 90
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) Scores at Baseline
timeFrame: Baseline
measure: Positive and Negative Syndrome Scale (PANSS) Scores at Day 90
timeFrame: Day 90
measure: Clinical Global Impression-Severity (CGIS) Scores at Baseline
timeFrame: Baseline
measure: Clinical Global Impression-Severity (CGIS) Scores at Day 90
timeFrame: Day 90
measure: Personal and Social Performance (PSP) Scores at Baseline
timeFrame: Baseline
measure: Personal and Social Performance (PSP) Scores at Day 90
timeFrame: Day 90
measure: Patient Satisfaction With Paliperidone Treatment
timeFrame: 90 days
measure: Quality of Sleep at Baseline
timeFrame: Baseline
measure: Quality of Sleep at Day 90
timeFrame: Day 90
measure: Daytime Drowsiness at Baseline
timeFrame: Baseline
measure: Daytime Drowsiness at Day 90
timeFrame: Day 90
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical Trial
role: STUDY_DIRECTOR
References: