Clinical trial NCT01362439: Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years
Official title: Efficacy and Tolerability of Flexible Doses of Paliperidone ER in Symptomatic Subjects With Schizophrenia With Duration of Illness < 10 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone
Lead sponsor: Janssen-Cilag S.p.A.
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were receiving treatment with any oral (having to do with the mouth) antipsychotic medication and who needed to be switched to paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or due to side effects.

Detailed description: This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of paliperidone ER in participants with schizophrenia who have a previous history of bad adherence to the antipsychotic treatment because of insufficient efficacy and side-effects. All the eligible participants will receive a dose of paliperidone ER in range of 3 to 12 milligram (mg) orally (taken by mouth; to be swallowed) once daily for 13 weeks. Efficacy and safety will primarily be evaluated by Positive and Negative Syndromes Scale (PANSS) and Extrapyramidal Symptom Rating Scale (ESRS), respectively. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
* Positive and Negative Syndrome Scale (PANSS) total score at Baseline of greater than equal to 70 and less than equal to 100
* Participants who need to be switched from the current oral antipsychotic therapy because of lack of efficacy or side effects
* Participants followed as outpatients
* Female participants must be postmenopausal for at least 1 year, surgically sterile or, if sexually active, be practicing an effective method of birth control and female participants of childbearing potential must also have a negative urine pregnancy test at Baseline

Exclusion Criteria:

* Acute psychotic relapse that requires hospitalization and first antipsychotic treatment ever
* Participants who had received clozapine during the previous 3 months
* History or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body) and neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
* Pregnant or breast-feeding female
* Participated in an investigational drug trial in the previous 30 days

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13
timeFrame: Baseline and Week 13
Secondary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13
timeFrame: Baseline and Week 13
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13
timeFrame: Baseline and Week 13
measure: Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13
timeFrame: Baseline and Week 13
measure: Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score
timeFrame: Baseline and Week 13
measure: Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13
timeFrame: Baseline and Week 13
measure: Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13
timeFrame: Baseline and Week 13
measure: Clinical Global Impression-Severity Scale (CGI-S)
timeFrame: Baseline and Week 13
measure: Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13
timeFrame: Baseline and Week 13
measure: Quality of Sleep Score
timeFrame: Baseline and Week 13
measure: Daytime Drowsiness Evaluation Scale
timeFrame: Baseline and Week 13
measure: Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
timeFrame: Baseline and Week 13
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag S.p.A.
name: Janssen-Cilag S.p.A. Italy Clinical Trial
role: STUDY_DIRECTOR
References: