A Phase 4 interventional study of Treatment as usual (TAU), Paliperidone ER in Schizophrenia, Schizoaffective Disorder and Psychotic Disorders, sponsored by Ortho-McNeil Janssen Scientific Affairs, LLC. Completed at 21 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-25.
Sponsored by Ortho-McNeil Janssen Scientific Affairs, LLC · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 121 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Ortho-McNeil Janssen Scientific Affairs, LLC is the lead sponsor of 16 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Drug: Treatment as usual (TAU), Paliperidone ER
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
The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER
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.
Time frame: Day 1 - Day 62
Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline
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.
Time frame: Day 1 - Day 62
Clinical Global Impression of Severity (CGI-S) Change From Baseline
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.
Time frame: Day 1 - Day 62
Personal and Social Performance Score (PSP) Change From Baseline
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.
Time frame: Day 1 - Day 62
One-hundred-twenty-one (121) participants were enrolled but only 114 entered Phase 1 of the study (5 participants enrolled twice and only had their first entrance included and 2 participants did not sign the required HIPAA form).
| Milestone | Study Treatment |
|---|---|
| Started | 114 |
| Completed | 85 |
| Not completed | 29 |
| Withdrew: Adverse event | 3 |
| Withdrew: Lost to follow-up | 7 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: (eligibility) | 8 |
| Withdrew: (protocol violation) | 1 |
| Withdrew: (pi decision) | 1 |
| Withdrew: (diagnosis) | 3 |
| Milestone | Study Treatment |
|---|---|
| Started | 84 |
| Completed | 69 |
| Not completed | 15 |
| Withdrew: Adverse event | 2 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Subject non-compliance | 2 |
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.
| Scores on a scale | Study Treatment |
|---|---|
| Day 27 (n=79) | -1.7 ± 7.35 |
| Day 48 (n=74) | -5.4 ± 8.72 |
| Day 62 (n=77) | -7.2 ± 9.91 |
| Post Day 27 Endpoint (n=79) | -7.6 ± 10.43 |
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.
| Scores on a scale | Study Treatment |
|---|---|
| Day 13 (n=78) | -0.1 ± 0.39 |
| Day 27 Paliperidone ER Baseline (n=79) | -0.1 ± 0.37 |
| Day 48 (n=74) | -0.3 ± 0.60 |
| Day 62 (n=77) | -0.4 ± 0.65 |
| Post Day 27 Endpoint (n=79) | -0.4 ± 0.67 |
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.
| Scores on a scale | Study Treatment |
|---|---|
| Day 27 Paliperidone ER Baseline (n=78) | 1.2 ± 7.25 |
| Day 62 (n=76) | 2.8 ± 7.23 |
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.
| Participants | TAU Phase | Paliperidone ER Phase |
|---|---|---|
| Serious Adverse Events | 0 | 2 |
| Other Adverse Events | 27 | 43 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TAU - Pali ER | — | 0/84 (0%) | 27/84 (32.1%) |
| Paliperidone ER Phase | — | 2/84 (2.4%) | 43/84 (51.2%) |
| TAU - All Enrolled Participants | — | 2/114 (1.8%) | 32/114 (28.1%) |
| Event | TAU - Pali ER | Paliperidone ER Phase | TAU - All Enrolled Participants |
|---|---|---|---|
| DystoniaNervous system disorders | 0/84 | 1/84 | 0/114 |
| Psychotic DisorderPsychiatric disorders | 0/84 | 1/84 | 0/114 |
| Cerebrovascular AccidentNervous system disorders | 0/84 | 0/84 | 1/114 |
| Gastrointestinal HaemorrhageGastrointestinal disorders | 0/84 | 0/84 | 1/114 |
| Event | TAU - Pali ER | Paliperidone ER Phase | TAU - All Enrolled Participants |
|---|---|---|---|
| TremorNervous system disorders | 2/84 | 7/84 | 2/114 |
| HeadacheNervous system disorders | 3/84 | 6/84 | 3/114 |
| NauseaGastrointestinal disorders | 1/84 | 5/84 | 1/114 |
| Weight IncreasedInvestigations | 5/84 | 3/84 | 5/114 |
| InsomniaPsychiatric disorders | 0/84 | 4/84 | 0/114 |
| DiarrhoeaGastrointestinal disorders | 1/84 | 3/84 | 1/114 |
| Dry MouthGastrointestinal disorders | 1/84 | 3/84 | 1/114 |
| Blood Pressure IncreasedInvestigations | 1/84 | 3/84 | 1/114 |
| Blood Prolactin IncreasedInvestigations | 1/84 | 3/84 | 1/114 |
| VomitingGastrointestinal disorders | 1/84 | 2/84 | 1/114 |
| Age, Continuous(years) | Study Treatment |
|---|---|
| Mean | 48.9 ± 6.73 |
| Sex: Female, Male(Participants) | Study Treatment |
|---|---|
| Female | 27 |
| Male | 57 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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