A Randomized, Active-Controlled, Double-Blind, Parallel-Goup Study of the Efficacy and Safety of Extended Release(ER) Paliparidone in the Treatment of Schizophrenia - Full Text View

Sponsored by:	Xian-Janssen Pharmaceutical Ltd.
Information provided by:	Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier:	NCT00350467

Purpose

This is a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), active-controlled, flexible-dose, parallel group, multicenter study. The study consists of a screening phase, a double-blind treatment phase (6 weeks) and a safety follow-up phase (1 week). The patients in this study will be randomized to 1 of 2 treatment groups to receive extended release OROS paliperidone or Olanzapine once daily for the 6-week double-blind treatment phase. Randomization will occur in a ratio of 1 (extended release OROS paliperidone) to 1 (Olanzapine). Patients must be hospitalized at least 14 days after entry. Those who receive extended release OROS paliperidone will start at a dosage of 6 mg taken daily, dose may be titrated up by 3mg/day every 7 days, or down rapidly based on the balance of efficacy (effectiveness of drug) and safety/tolerability assessed by the investigator. After the initial 7 days, dose could be flexible within 3-12mg/day. Those who receive olanzapine will start at a dosage of 5mg taken daily, dose may be titrated up by 5mg/day every 7 days, or down rapidly based on the balance of efficacy and safety/tolerability assessed by the investigator. After the initial 7 days, dose could be flexible within 5-15mg/day. Efficacy parameters include Positive and Negative Symptom Scale (PANSS) score, Clinical Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) score per assessment visit. The primary efficacy is the change in PANSS from baseline to the last post-randomization assessment. Safety assessments include the adverse events, changes in physical examination, vital signs, laboratory tests at pretreatment and posttreatment.

Condition	Intervention	Phase
Acute Schizophrenia	Drug: ER OROS paliperidone and Olanzapine	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine Paliperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, 6-Week Double-Blind, Parallel Study to Evaluate the Efficacy and the Safety of Flexible Doses of Extended Release OROS Paliperidone Compared With Olanzapine in the Treatment of Patients With Schizophrenia

Further study details as provided by Xian-Janssen Pharmaceutical Ltd.:

Primary Outcome Measures:

Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline.

Secondary Outcome Measures:

Changes in PANSS positive and negative scores at each assessment time point from baseline; Changes in CGI-S at each assessment time point from baseline; Changes in PSP at each assessment time point from baseline

Estimated Enrollment:	300
Study Start Date:	July 2006
Study Completion Date:	December 2006

Detailed Description:

The study hypothesis is that the effect of extended release OROS paliperidone is not worse than that of Olanzapine in the treatment of schizophrenia as measured by the change in PANSS from baseline to the last post-randomization assement.

A flexible dose range is used in this study. The flexible dose of paliperidone is ranged from 3 to 12mg/day. The flexible dose of olanzapine is ranged from 5-15mg/day.The study medication is capsulized to maintanin blind. Study medication must be taken orally once daily before 10 AM with or without food in a consistant manner throughout the study. Medication can not be chewed, divided, dissolved, or crushed. Treatment duration is 6 week each subject.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients (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
DSM-IV diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) at entry
Total PANSS score at screening and baseline between 60 and 120, inclusive
Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before entry (and agree to continue that method throughout the study) - abstinence is not an acceptable method
Have a negative urine b hCG pregnancy test at screening
Capable of self-administering study drug, or has consistent help and support available throughout the study to do this

Exclusion Criteria:

A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) Axis I diagnosis other than schizophrenia
Inability to swallow the study drug whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug, as this may affect the release profile)
Previous history of a lack of response to any antipsychotic (lack of response defined as subject having had least twice a documented medical history of no clinical response despite adequate doses and durations of treatment, or the inability to tolerate effective doses)
Significant risk of suicidal or violent behavior
Injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
Use of monoamine oxidase inhibitors within 4 weeks before screening
Use of antidepressants other than monoamine oxidase inhibitors or mood stabilizers (e.g., antiepileptics, lithium) within 2 weeks before screening
Received electroconvulsive therapy within 3 months before screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350467

Locations

China

Xian, China

Beijing, China

Shanghai, China
China, Guangdong

Guangzhou, Guangdong, China
China, Hubei

Wuhan, Hubei, China
China, Jiangsu

Nanjing, Jiangsu, China
China, Zhejiang

Suzhou, Zhejiang, China

Sponsors and Collaborators

Xian-Janssen Pharmaceutical Ltd.

Investigators

Study Director:

Xian-Janssen Pharmaceutical Ltd. Clinical Trial

Xian-Janssen Pharmaceutical Ltd.

More Information

A Randomized, 6-Week Double Blind, Parallel Study to Evaluate the Efficacy and the Safety of Flexible Doses of Extended Release OROS Paliperidone Compared with Olanzapine in the Treatment of Patients With Schizophrenia This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Fowler JA, Bettinger TL, Argo TR. Paliperidone extended-release tablets for the acute and maintenance treatment of schizophrenia. Clin Ther. 2008 Feb;30(2):231-48.

Study ID Numbers:	CR010861
Study First Received:	July 7, 2006
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00350467
Health Authority:	China: State Food and Drug Administration

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:

informed consent
DSM-IV
PANSS
Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Risperidone
Olanzapine

9-hydroxy-risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009