A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Paliperidone ER

Study type

Interventional

Funder types

Industry

Identifiers

NCT01606228

PAL-PHL-MA3 (Other Identifier)

R076477SCH3033 (Other Identifier)

CR014452

Details and patient eligibility

About

The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.

Full 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.

Enrollment

188 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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