Efficacy and Tolerability of Flexible Doses of Paliperidone ER in Symptomatic Subjects With Schizophrenia With Duration of Illness < 10 Years
Overview
- Phase
- Phase 4
- Intervention
- Paliperidone ER
- Conditions
- Schizophrenia
- Sponsor
- Janssen-Cilag S.p.A.
- Enrollment
- 133
- Primary Endpoint
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Arms & Interventions
Paliperidone ER
Intervention: Paliperidone ER
Outcomes
Primary Outcomes
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13
Time Frame: Baseline and Week 13
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. 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.
Secondary Outcomes
- Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13(Baseline and Week 13)
- Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score(Baseline and Week 13)
- Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13(Baseline and Week 13)
- Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13(Baseline and Week 13)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13(Baseline and Week 13)
- Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13(Baseline and Week 13)
- Clinical Global Impression-Severity Scale (CGI-S)(Baseline and Week 13)
- Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13(Baseline and Week 13)
- Quality of Sleep Score(Baseline and Week 13)
- Daytime Drowsiness Evaluation Scale(Baseline and Week 13)
- Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores(Baseline and Week 13)