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

An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Paliperidone ER

Detailed Description

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
• Enrollment (Actual): 95
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
  • Buenos Aires N/A, Argentina
  • Rosario, Argentina
• Colombia
  • Bogota, Colombia
  • Cali, Colombia
  • Medellin, Colombia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paliperidone ER	Drug: Paliperidone ER; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	Baseline, Week 26
Personal and Social Performance (PSP) Scale	This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.	Baseline, Week 26
Health Status as Measured by Self-rated Health Status Survey SF-36	The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.	Baseline, Week 26
Sleep Evaluation Scale	This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).	Baseline, Week 26
Daytime Drowsiness Evaluation Scale	This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).	Baseline, Week 26

Collaborators and Investigators

• Sponsor: Janssen-Cilag, S.A.
• Investigators: Study Director: Janssen-Cilag S.A. Clinical Trial, Janssen-Cilag, S.A.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 7, 2012
• First Posted (Estimate): November 9, 2012

Study Record Updates

• Last Update Posted (Estimate): March 15, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Schizophrenia; Paliperidone extended-release (ER); Antipsychotic agents
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate
• Other Study ID Numbers: CR017413; R076477SCH3029 (Other Identifier: Janssen-Cilag Colombia); R076477SCH3036 (Other Identifier: Janssen-Cilag Argentina)