Clinical trial NCT00396565: A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia
Official title: A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
JNS007ER
Positive and Negative Syndrome Scale (PANSS)
Paliperidone
Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2006-11-07
Enrollment: 394
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.

Detailed description: This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients who have given their own consent in writing to participate in the study
* Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60)
* Patients who have acute symptoms of schizophrenia
* Both inpatients and outpatients are acceptable

Exclusion Criteria:

* A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia
* A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test
* Total PANSS (Positive and Negative Syndrome System) score at the screening test \<70 or \>120
* Patients treated with three or more types of antipsychotic within 28 days before the screening test
* Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)
* Patients with a complication of or a past history of cerebrovascular accident
* Patients with a complication of or a past history of diabetes mellitus

Primary outcomes:
measure: Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
timeFrame: Baseline and 6 weeks
measure: Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Clinical Global Impression Scale (CGI-S)
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Aizuwakamatsu
country: Japan
city: Fujioka
country: Japan
city: Fujisawa
country: Japan
city: Fukui
country: Japan
city: Hadano
country: Japan
city: Himeji
country: Japan
city: Hiratsuka
country: Japan
city: Hiroshima
country: Japan
city: Ibaraki
country: Japan
city: Ichikawa
country: Japan
city: Iida
country: Japan
city: Inazawa
country: Japan
city: Itoman
country: Japan
city: Kaizuka
country: Japan
city: Kanzaki
country: Japan
city: Kashihara
country: Japan
city: Kitakyushu
country: Japan
city: Kochi
country: Japan
city: Koushi N/A
country: Japan
city: Kumamoto
country: Japan
city: Kurayoshi
country: Japan
city: Matsudo
country: Japan
city: Matsusaka
country: Japan
city: Moriguchi
country: Japan
city: Morioka
country: Japan
city: Nagoya
country: Japan
city: Naha
country: Japan
city: Nakagami
country: Japan
city: Nankoku
country: Japan
city: Nishinomiya
country: Japan
city: Noda
country: Japan
city: Numazu
country: Japan
city: Ohta
country: Japan
city: Oita
country: Japan
city: Okinawa
country: Japan
city: Oyama
country: Japan
city: Sakai
country: Japan
city: Sapporo
country: Japan
city: Takasaki
country: Japan
city: Takatsuki
country: Japan
city: Tanba
country: Japan
city: Togane
country: Japan
city: Tokyo
country: Japan
city: Tottori
country: Japan
city: Toyama
country: Japan
city: Toyoake
country: Japan
city: Toyonaka
country: Japan
city: Tsuyama
country: Japan
city: Ueda
country: Japan
city: Urasoe
country: Japan
city: Uruma
country: Japan
city: Yanagawa
country: Japan
city: Yao
country: Japan
city: Yokkaichi
country: Japan
city: Yokohama
country: Japan
city: Yokosuka
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References: