Clinical trial NCT00566631: An Efficacy and Safety Study of Paliperidone Extended-Release (ER) Tablets in Participants With Schizophrenia
Official title: Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone Extended Release (ER)
Invega
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2007-12-03
Enrollment: 294
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 the tolerability, safety and treatment response of flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with acute schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description: This is an open-label (all people know the identity of the intervention), single-arm (getting one dose of medicine), multi-center (conducted in more than 1 center) study to evaluate tolerability, safety and efficacy of flexible daily doses of paliperidone ER in participants with acute schizophrenia. All participants will be given paliperidone ER once daily at a dose of 3, 6, 9, or 12 milligram (mg) tablets orally depending on Investigator's discretion, based on participant's clinical response and tolerability towards paliperidone ER. The duration of the core phase of the treatment will be 6 weeks and the participants who will complete this phase, respond well and would like to continue, will be eligible to be enrolled in an extension phase, which is no longer than 12 months. Efficacy will primarily be evaluated by treatment response evaluated through total Positive and Negative Syndrome Scale (PANSS) score. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia
* Must be experiencing an acute schizophrenic episode with a Positive and Negative Syndrome Scale (PANSS) total score of greater than or equal to 70 at Baseline
* Must be admitted to hospital for treatment of the acute schizophrenic episode and must agree for voluntary hospitalization for at least the first 7 days of the study
* Female participants must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study and female participants of child-bearing potential must have a negative urine pregnancy test at Screening
* Participants or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Pregnant or breast-feeding female participants
* First antipsychotic treatment ever
* Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment and on clozapine or a long-acting injectable antipsychotic during the last 3 months
* Known hypersensitivity to paliperidone extended-release (ER) or risperidone
* Relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome including recent or present clinically relevant laboratory abnormalities (as deemed by the Investigator) and participants with current or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria

Primary outcomes:
measure: Number of Participants With Treatment Response Based on Total PANSS Scale Score
timeFrame: Day 42 or early discontinuation
Secondary outcomes:
measure: Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
timeFrame: Baseline, Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
timeFrame: Baseline, Day 42 and Final Evaluation (Day 42 or early discontinuation)
measure: Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
timeFrame: Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
measure: Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
timeFrame: Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
measure: Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
timeFrame: Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
measure: Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
timeFrame: Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
measure: Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
timeFrame: Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
measure: Number of Participants Satisfied With the Study Treatment
timeFrame: Day 42 or early discontinuation
Other outcomes:
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
timeFrame: Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)
measure: Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
timeFrame: Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)
measure: Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
timeFrame: Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)
Locations:
city: Zagreb
country: Croatia
city: Dieppe N/A
country: France
city: La Charite Sur Loire
country: France
city: Metz Cedex 01
country: France
city: Augsburg
country: Germany
city: Bonn
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: München
country: Germany
city: Rostock
country: Germany
city: Wasserburg
country: Germany
city: Be-Er Ya-Acov
country: Israel
city: Beer Sheva
country: Israel
city: Hod-Hasharon
country: Israel
city: Pardesia
country: Israel
city: Ramat Gan
country: Israel
city: Klaipeda
country: Lithuania
city: Siauliai
country: Lithuania
city: Vilnius
country: Lithuania
city: Gda Sk Poland
country: Poland
city: Lubliniec
country: Poland
city: Lublin
country: Poland
city: Skape
country: Poland
city: Swiecie
country: Poland
city: Torun N/A
country: Poland
city: Zabki
country: Poland
city: Łódź
country: Poland
city: Bucharest
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV, Belgium Clinical Trial
role: STUDY_DIRECTOR
References: