- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00535145
Study to Measure the Safety of Paliperidone ER (Extended-release) in Patients With Liver Disease
A Single-arm Evaluation of the Safety of Paliperidone Extended-Release (ER) in Subjects With Schizophrenia or Schizoaffective Disorder With Hepatic Disease
Study Overview
Status
Intervention / Treatment
Detailed Description
Patients with schizophrenia or schizoaffective disorder commonly have other conditions that may affect the liver, such as alcohol abuse and/or chronic liver infections (hepatitis). Although single-dose studies in patients with liver disease are conducted to test the safety of medications, there is less information about the safety of treatment with medications for schizophrenia in this at-risk population of patients with schizophrenia or schizoaffective disorder and liver disease. This 9-week study is open-label (both patient and investigators know what study drug and dose of study drug the patient is taking) and has 2 phases. During Phase 1, which lasts 4 weeks, patients will continue to take whatever medication they are already taking for schizophrenia (TAU, or treatment as usual). During the first week of Phase 2, patients will receive decreasing doses of TAU and increasing doses of paliperidone ER. For the rest of Phase 2, which lasts 4 more weeks, patients will take paliperidone ER in doses between 3 mg/day and 12 mg/day, as prescribed by the study doctor. This study will evaluate adverse events and will use several scales and tests to measure the effectiveness of paliperidone ER in patients with an established diagnosis of schizophrenia or schizoaffective disorder and liver disease. Study assessments include the PANSS (Positive and Negative Symptom Scale for Schizophrenia), CGI (Clinical Global Impression scale), MSQ (Medication Satisfaction Questionnaire), sleep VAS (Visual Analog Scale), SF-36 (Short Form 36 Health Survey), and PSP (Personal and Social Performance Scale). Each assessment will be performed at least two times during the course of the study, but some assessments will be done more frequently. Visits are scheduled every 1 to two weeks during the 9 week study.
The hypothesis is that paliperidone ER can be used safely in patients with schizophrenia or schizoaffective disorder who also have identified liver disease. During Phase 1 of the study, patients will continue to take whatever medication they are already taking for schizophrenia (TAU, or treatment as usual) for 4 weeks. For the first week of Phase 2, patients will receive decreasing doses of TAU. During Phase 2, patients will take paliperidone ER in doses between 3 milligrams per day and 12 milligrams per day by mouth for 5 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Cerritos, California, United States
-
Chino, California, United States
-
Garden Grove, California, United States
-
Huntington Beach, California, United States
-
Santa Ana, California, United States
-
Torrance, California, United States
-
-
Florida
-
Fort Lauderdale, Florida, United States
-
Hollywood, Florida, United States
-
Kissimmee, Florida, United States
-
-
Louisiana
-
Lake Charles, Louisiana, United States
-
-
Mississippi
-
Flowood, Mississippi, United States
-
-
Missouri
-
Kansas City, Missouri, United States
-
-
New Jersey
-
Clementon, New Jersey, United States
-
-
New Mexico
-
Albuquerque, New Mexico, United States
-
-
New York
-
Staten Island, New York, United States
-
-
Ohio
-
Cincinnati, Ohio, United States
-
-
Pennsylvania
-
Norristown, Pennsylvania, United States
-
Philadelphia, Pennsylvania, United States
-
-
South Dakota
-
Sioux Falls, South Dakota, United States
-
-
Texas
-
Irving, Texas, United States
-
-
Vermont
-
White River Junction, Vermont, United States
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study, and must also have a negative urine pregnancy test at Screening
- Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
- Must have identified current, stable liver disease (e.g., viral hepatitis, alcoholic cirrhosis)
- Child-Pugh class A or B (total score < 10)
Exclusion Criteria:
- Not able to swallow the study medication whole with the aid of water
- Not currently meeting criteria for any other Axis I diagnosis, including a DSM-IV diagnosis of Bipolar Disorder
- Not using alcohol in the previous 2 weeks or meeting the DSM-IV criteria for substance abuse or dependence or alcohol abuse or dependence in the 6 months before study entry
- Not experiencing severe liver disease or an acute exacerbation of the underlying liver disease (Child-Pugh total score >=10)
- No evidence of severe hepatic decompensation within the previous 3 months, such as: ascites not controlled with diuretics, peritonitis, portal hypertension or gross hepatic encephalopathy (eg, somnolence, stupor, coma)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
Treatment as usual (TAU), Paliperidone ERTreatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks
|
Treatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER
Time Frame: Day 1 - Day 62
|
Adverse Event summary for both serious adverse events and other adverse events.
Please see the Clinical Study Report Synopsis for results on this primary outcome measure or the AE section for a detailed breakdown of each adverse event preferred term in both categories.
|
Day 1 - Day 62
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline
Time Frame: Day 1 - Day 62
|
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control.
The 30 symptoms are rated on a 7-point scale (1="Absent", 2="Minimal", 3="Mild", 4="Moderate", 5="Moderate/Severe", 6="Severe", 7="Extreme").The PANSS total score consists of the sum of all 30 PANSS items.
Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.
|
Day 1 - Day 62
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Time Frame: Day 1 - Day 62
|
The CGI-S (range 1-7) is a standardized, clinician-rated assessment to rate the severity of illness of the patient.
The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill.
The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness.
|
Day 1 - Day 62
|
Personal and Social Performance Score (PSP) Change From Baseline
Time Frame: Day 1 - Day 62
|
The PSP (range 1-100) is a validated clinician-rated assessment of functioning.
Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe).
A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.
|
Day 1 - Day 62
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Disease
- Psychotic Disorders
- Mental Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Paliperidone Palmitate
Other Study ID Numbers
- CR014341
- R076477SCH4005 (Other Identifier: Ortho McNeil Janssen Scientific Affairs, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychotic Disorders
-
Medical College of WisconsinCompletedSchizophrenia | Affective Disorders | Psychotic Disorder | Psychotic Mood Disorder
-
Søren Dinesen ØstergaardCompletedAffective Disorders, PsychoticDenmark
-
Instituto de Investigación Hospital Universitario...CompletedSchizophrenia and Disorders With Psychotic Feature | Psychotic EpisodeSpain
-
Instituto de Investigación Hospital Universitario...Carlos III Health Institute; European Regional Development FundCompletedSchizophrenia and Disorders With Psychotic Features | Psychotic EpisodeSpain
-
University of MinnesotaUniversity of California, San FranciscoCompletedPsychotic Disorders | Schizophrenia | Schizoaffective Disorder | Cognitive Impairment | Psychosis | Treatment | Psychotic Depression | Psychotic Episode | Active Control | Psychotic Mood DisordersUnited States
-
Centre hospitalier de Ville-Evrard, FranceRecruiting
-
VA Office of Research and DevelopmentNot yet recruitingMI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMIHomelessness | Schizophrenia Spectrum Disorders | Psychotic Mood Disorders | Psychotic Affective Disorders | Ill-Housed PersonsUnited States
-
University of California, San DiegoActive, not recruitingSchizophrenia | Schizoaffective Disorder | Mood Disorder, PsychoticUnited States
-
University Hospital, CaenRecruiting
-
Boston Medical CenterNational Institute of Mental Health (NIMH); Beth Israel Deaconess Medical CenterCompletedPsychotic Disorders | Psychosis | Psychotic EpisodeUnited States
Clinical Trials on Treatment as usual (TAU), Paliperidone ER
-
Centro Mente Aberta de MindfulnessUnknown
-
Academisch Medisch Centrum - Universiteit van Amsterdam...KU Leuven; ZonMw: The Netherlands Organisation for Health Research and Development and other collaboratorsRecruiting
-
Hospital Universitari Vall d'Hebron Research InstituteParc Sanitari Sant Joan de Déu; Universitat Autonoma de BarcelonaCompleted
-
Centre for Addiction and Mental HealthCompleted
-
Nova Scotia Health AuthorityCompletedEating DisordersCanada
-
Virginia Commonwealth UniversityCompletedSubstance Use Disorders | Substance Abuse | Drug Abuse | Drug Addiction | Drug Dependence | Drug Use Disorders | Substance AddictionUnited States
-
Hospital Universitari Vall d'Hebron Research InstituteActive, not recruiting
-
University of BariUniversity of Dublin, Trinity CollegeCompletedRecovery | Mental Disorder | Schizophrenia and Related Disorders | Intellectual Disability, Mild to Moderate | Personality Disorders and Disturbances in Behavior | Personality Disorders, AntisocialItaly
-
Fundació Sant Joan de DéuUniversitat Autonoma de BarcelonaRecruiting
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedSubstance AbuseUnited States