Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia

Janssen-Cilag, S.A.95 enrolled

Overview

The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.

This is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6, 9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally. Adjustment of the dosage will be done at the investigator's discretion, based on the individual patient's clinical response and tolerability to the study drug.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

Paliperidone ERDRUG

The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient meets the criteria for schizophrenia * Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication * Patient is healthy on the basis of a physical examination and vital signs at screening * Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study Exclusion Criteria: * Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months * Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities * Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome * Patients judged to be at high risk for adverse events, violence, or self-harm * Patients with known hypersensitivity to paliperidone ER or to risperidone * Patients with a current use or known history (over the past 6 months) of substance dependence

Locations (5)

Unnamed facility

Buenos Aires, Argentina

Unnamed facility

Rosario, Argentina

Unnamed facility

Bogotá, Colombia

Unnamed facility

Cali, Colombia

Unnamed facility

Medellín, Colombia

Outcomes

Primary Outcomes

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

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

Time frame: Baseline, Week 26

Secondary Outcomes

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

The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).

Time frame: Baseline, Week 26

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

The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).

Time frame: Baseline, Week 26

Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score

The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).

Time frame: Baseline, Week 26

Clinical Global Impression-Severity (CGIS)

The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.

Data from ClinicalTrials.gov

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