An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00524043 |
Recruitment Status :
Completed
First Posted : September 3, 2007
Results First Posted : February 26, 2010
Last Update Posted : June 4, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Paliperidone ER Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 201 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of a Fixed Dosage of 1.5 mg/Day of Paliperidone Extended Release (ER) in the Treatment of Subjects With Schizophrenia |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | November 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 001
Paliperidone ER 1.5 mg tablet once daily for 6 weeks
|
Drug: Paliperidone ER
1.5 mg tablet once daily for 6 weeks |
Active Comparator: 002
Paliperidone ER 6 mg tablet once daily for 6 weeks
|
Drug: Paliperidone ER
6 mg tablet once daily for 6 weeks |
Placebo Comparator: 003
Placebo Once daily for 6 weeks
|
Drug: Placebo
Once daily for 6 weeks |
- Change From Baseline in PANSS Total Score at the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment). [ Time Frame: Baseline, 6 weeks ]The Positive and Negative Syndrome Scale (PANSS) is a tool used by psychiatrists to measure the symptoms of psychosis experienced by a patient with schizophrenia. It includes 30 items that produce a total score ranging from a minimum of 30 (indicating least severe symptoms of illness) to a maximum of 120 (indicating most severe symptoms of illness). A negative change in score from baseline to end point indicates improvement in the symptoms of illness.
- Change From Baseline to the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment) in CGI-S [ Time Frame: Baseline, 6 weeks ]The Clinical Global Impression-Severity (CGI-S) rating scale is used by psychiatrists to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). The scale permits a global evaluation of the patient's condition at a given time.
- Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in PSP Score [ Time Frame: Baseline, 6 weeks ]The Personal and Social Performance (PSP) scale assesses the degree of difficulty (ranging from i [absent] to vi [very severe]) a patient exhibits over a 1-month period in socially useful activities, personal and social relationships, self care, and disturbing and aggressive behavior. The overall score ranges from 1 to 100. Patients with scores of 71 to 100 have a mild degree of difficulty; patients with scores from 31 to 70 have various degrees of disability; and patients with scores of 30 or less function so poorly as to require intensive supervision.
- Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Physical Component Summary Scale Score [ Time Frame: Baseline, 6 weeks ]The Medical Outcomes Study Short Form Health Survey-36 (MOS SF-36) is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary.
- Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Mental Component Summary Scale Score [ Time Frame: Baseline, 6 weeks ]The MOS SF-36 is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year before screening
- Experiencing an acute episode with a total PANSS score at screening of between 70 and 120
- Are otherwise physically healthy
- Agree to at least 8 days of voluntary hospitalization.
Exclusion Criteria:
- Active comorbid DSM-IV axis I diagnosis other than schizophrenia (nicotine and caffeine dependence are not exclusionary)
- Treatment with antidepressants (unless a subject has been on a stable dosage for at least 3 months before baseline) other than monoamine oxidase inhibitors
- DSM-IV diagnosis of substance dependence within 6 months before screening evaluation (nicotine and caffeine dependence are not exclusionary)
- Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renal disease
- Relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic disease.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524043
United States, California | |
Cerritos, California, United States | |
Torrance, California, United States | |
United States, District of Columbia | |
Washington, District of Columbia, United States | |
United States, Florida | |
Bradenton, Florida, United States | |
Leesburg, Florida, United States | |
United States, Georgia | |
Atlanta, Georgia, United States | |
United States, Maryland | |
Rockville, Maryland, United States | |
United States, New Jersey | |
Nutley, New Jersey, United States | |
United States, New York | |
Cedarhurst, New York, United States | |
Hollis, New York, United States | |
United States, Oklahoma | |
Moore, Oklahoma, United States | |
United States, Texas | |
Austin, Texas, United States | |
India | |
Calicut, India | |
Hyderabad, India | |
Mumbai, India | |
Pune, India | |
Varanasi, India | |
Taiwan | |
Hualien, Taiwan | |
Tainan, Taiwan | |
Taipei, Taiwan |
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Additional Information:
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00524043 History of Changes |
Other Study ID Numbers: |
CR013771 R076477SCH4012 |
First Posted: | September 3, 2007 Key Record Dates |
Results First Posted: | February 26, 2010 |
Last Update Posted: | June 4, 2014 |
Last Verified: | May 2014 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia |
Additional relevant MeSH terms:
Paliperidone Palmitate Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |
Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine D2 Receptor Antagonists Dopamine Antagonists Dopamine Agents |