A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia

Janssen Research & Development, LLC212 enrolled

Overview

The purpose of this study is to evaluate the effectiveness and safety of paliperidone palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute schizophrenia (that is within past 4 weeks).

This is an open-label (all people know the identity of the intervention), prospective (looking forward using periodic observations collected predominantly following participant enrollment), non-comparative and multicenter study to evaluate the effectiveness and safety of paliperidone palmitate in acute schizophrenic participants. This study consists of a screening phase (up to 7 days), treatment phase (13 weeks), and a study completion or early withdrawal visit. Safety evaluations will include adverse events, clinical laboratory tests, concomitant medications, physical examination, and vital signs, which will be monitored throughout the study. The total duration of study participation for each participant will be approximately 13 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

212

Conditions

Schizophrenia

Interventions

Paliperidone palmitateDRUG

Participants will receive 1 intramuscular (into muscle) injection of 150 milligram (mg) on Day 1 and 1 injection of 100 mg on Day 8. Participants will also receive the last 2 paliperidone intramuscular injections between 50 - 150 mg (based on effectiveness and safety profile), on Day 36 and Day 64.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV) * Must be admitted to a hospital within 4 weeks prior to Screening experiencing an acute exacerbation of schizophrenia * Have a positive and negative syndrome scale (PANSS) total score of more than or equal to 60 or clinical global impressions - severity (CGI-S) score of more than or equal to 4 (moderately ill) at Screening * Agree to protocol-defined method of contraception * Must be medically stable based on physical examination, medical history, vital signs, and clinical laboratory tests performed at Screening Exclusion Criteria: * Have a primary active DSM-IV Axis I diagnosis other than schizophrenia * Have evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in medical history, clinical laboratory or physical examination * Have a history of neuroleptic malignant syndrome * Participants at risk of suicide * Have received clozapine within 1 month prior to Screening

Locations (21)

Unnamed facility

Huzhou, China

Unnamed facility

Shanghai, China

Unnamed facility

Shantou, China

Outcomes

Primary Outcomes

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

The PANSS is scale of 30 items which includes 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).

Time frame: Baseline (Week 0), Week 13

Secondary Outcomes

Number of Participants With at Least a 30 Percent Reduction From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

Time frame: Baseline, Week 13

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Scores

Marder factor scores of the PANSS, derived by factor-analysis includes 5 factors: negative symptom, positive symptom, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression factor scales. Positive factor score (range: 8 to 56): sum of select scores from positive, negative, and general psychopathology subscales. Negative factor score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales. Disorganized thoughts factor score (range: 7 to 49): sum of select scores from positive, negative, and general psychopathology subscales. Uncontrolled hostility/excitement factor score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales. Anxiety/Depression factor score (range: 4 to 28): sum of select scores from general psychopathology subscale. Higher scores indicate worsening.

Time frame: Baseline, Week 13

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores

Data from ClinicalTrials.gov

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