Clinical trial NCT01724359: Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia
Official title: An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone extended-release (ER)
Antipsychotic agents
Lead sponsor: Janssen-Cilag, S.A.
Sponsor class: INDUSTRY
First posted: 2012-11-09
Enrollment: 95
Sex: ALL
Minimum age (years): 18
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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
timeFrame: Baseline, Week 26
measure: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
timeFrame: Baseline, Week 26
measure: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
timeFrame: Baseline, Week 26
measure: Clinical Global Impression-Severity (CGIS)
timeFrame: Baseline, Week 26
measure: Personal and Social Performance (PSP) Scale
timeFrame: Baseline, Week 26
measure: Health Status as Measured by Self-rated Health Status Survey SF-36
timeFrame: Baseline, Week 26
measure: Sleep Evaluation Scale
timeFrame: Baseline, Week 26
measure: Daytime Drowsiness Evaluation Scale
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Buenos Aires N/A
country: Argentina
city: Buenos Aires
country: Argentina
city: Rosario
country: Argentina
city: Bogota
country: Colombia
city: Cali
country: Colombia
city: Medellin
country: Colombia
Study officials:
affiliation: Janssen-Cilag, S.A.
name: Janssen-Cilag S.A. Clinical Trial
role: STUDY_DIRECTOR
References: