Trial Evaluating Three Fixed Doses of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00083668
First received: May 27, 2004
Last updated: June 6, 2011
Last verified: March 2010
  Purpose

The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in adult patients with schizophrenia


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone ER
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Paliperidone Extended Release (ER) Tablets and Olanzapine, With Open-label Extension, in the Treatment of Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Change from baseline in the total PANSS score to the end of the double-blind phase.

Secondary Outcome Measures:
  • Changes from baseline to the end of the double-blind phase in PSP, CGI-S, and SQLS-R4.

Enrollment: 619
Study Start Date: April 2004
Study Completion Date: May 2005
Detailed Description:

Paliperidone is being developed as a new therapeutic agent for the treatment of schizophrenia. The extended-release (ER) formulation of paliperidone was developed to deliver paliperidone at a relatively constant rate over a 24-hour period to improve the tolerability profile and decrease the potential for orthostatic hypotension. This study is designed to evaluate the efficacy and safety and tolerability of 3 dosages of paliperidone ER compared with placebo in adult patients with schizophrenia. This is a multicenter, double-blind, randomized, placebo- and active-controlled, parallel-group, dose-response study. Patients will be randomized into 1 of 5 treatment groups to receive oral dosages of paliperidone ER 3, 9, or 15 mg, olanzapine 10 mg, or placebo once daily for a 6-week period. The study includes a screening period of up to 5 days, followed by a 6-week double-blind treatment phase. Following the double-blind treatment phase, eligible patients (those who have completed the 6-week double-blind phase or who discontinue due to lack of efficacy after a minimum of 21 days) may enter the 52-week open-label extension with paliperidone ER monotherapy. While patients are hospitalized, efficacy will be assessed twice during the first week and at the end of the second week, and after patients are discharged from the hospital, they will return to have efficacy and safety assessments performed on a weekly basis through the end of the 6-week double-blind phase. Efficacy will be evaluated throughout the 6-week double-blind phase by completion of the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale - Severity (CGI-S), Personal and Social Performance Scale (PSP), and Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4). The primary efficacy response will be measured by the change from baseline score to end of double-blind phase for PANSS total score. Safety will be monitored throughout the study and includes assessments of the incidence of adverse events; measurement of extrapyramidal symptoms using 3 rating scales (Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Rating Scale [BARS], Simpson-Angus Rating Scale [SAS]); measurement of vital signs (laying down and standing blood pressure, pulse, temperature); electrocardiograms; and clinical laboratory tests. Double-blind phase: 3, 9, 15 mg of paliperidone ER, 10 mg of olanzapine or placebo taken orally once a day for 6 weeks.

Open-label phase: start on paliperidone ER 9 mg orally once a day; maintained on a flexible oral dosage of paliperidone ER (3, 6, 9, 12, or 15 mg/day) for 52 weeks.

  Eligibility

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

Inclusion Criteria:

  • Double-blind phase: DSM-IV diagnosis of schizophrenia for at least 1 year
  • experiencing an acute episode, with a total PANSS score at screening between 70 and 120
  • agree to voluntary hospitalization for a minimum of 14 days
  • willing and able to fill out self-administered questionnaires
  • must be able to be compliant with self-administration of medication, or have consistent help/support available.

Open-label phase: have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy

  • patient and investigator must agree that open-label treatment is in the best interest of the patient.

Exclusion Criteria:

  • Double-blind phase: DSM-IV axis I diagnosis other than schizophrenia
  • DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
  • history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)
  • history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
  • previous history of a lack of response (2 adequate trials) to any antipsychotic
  • significant risk of suicidal or violent behavior. Open-label extension: patients believed by the investigator to be at significant risk for suicidal or violent behavior
  • received an injection of a depot antipsychotic since entry into the preceding double-blind phase.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083668

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00083668     History of Changes
Other Study ID Numbers: CR004375
Study First Received: May 27, 2004
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia
Paliperidone
Olanzapine
PANSS
Extended release
Atypical neuroleptic

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
9-hydroxy-risperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on August 28, 2014