- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01662648
Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia
April 17, 2014 updated by: Janssen Pharmaceutica
An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
The purpose of this study is to explore the efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were previously unsuccessfully treated with other oral antipsychotics.
Study Overview
Detailed Description
This is a single arm (one group of participants), multi-center, 6-month study to explore the tolerability, safety and efficacy of flexibly dosed paliperidone ER in participants with schizophrenia previously unsuccessfully treated with an oral antipsychotic medication.
Antipsychotic medications are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders.
Unsuccessfully treated means that, despite the participant was treated with an adequate dose of an appropriate oral antipsychotic for an adequate period of time, previous treatment is considered unsuccessful due to lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons.
Throughout the study the investigators will adjust the dosage of each participant based on the individual needs.
In general, the recommended paliperidone ER dose will be 6 milligram once daily.
Participants can be either in- or outpatients and they may take their study drug with or without food.
Participants who will complete this 6-month study and would like to continue will be eligible to be enrolled in an extension phase until paliperidone ER is available.
Study Type
Interventional
Enrollment (Actual)
1117
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant diagnosed with schizophrenia
- Participant's previous treatment of schizophrenia is considered unsuccessful
- Participant is healthy on the basis of a physical examination and vital signs
- Women must be postmenopausal, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
- Be willing and able to fill out self-administered questionnaires
Exclusion Criteria:
- Have used clozapine or Risperdal CONSTA during the last month, or have received any other conventional drug used to treat psychosis during the last 3 months
- Judged to be at high risk for adverse events, violence or self-harm
- Inability to swallow the study medication whole with the aid of water
- Pregnant or breast-feeding female
- History or current symptoms of tardive dyskinesia (involuntary movements of the facial muscles and tongue)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Paliperidone ER: Lack of efficacy
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
|
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion.
|
Experimental: Paliperidone ER: Lack of tolerability, compliance or other
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
|
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26
Time Frame: Baseline and Week 26
|
The PANSS is a 30-item scale 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 that ranges from 1 (absent) to 7 (extreme psychopathology).
The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210.
Higher scores indicate worsening.
Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
|
Baseline and Week 26
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26
Time Frame: Week 26
|
The PANSS is a 30-item scale 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 that ranges from 1 (absent) to 7 (extreme psychopathology).
The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210.
Higher scores indicate worsening.
Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here.
Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
|
Week 26
|
Change From Baseline in PANSS Total Positive Subscale Score at Week 26
Time Frame: Baseline and Week 26
|
The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia.
Positive symptoms refer to an excess of or distortion of normal functions.
The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology).
Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
|
Baseline and Week 26
|
Change From Baseline in PANSS Total Negative Subscale Score at Week 26
Time Frame: Baseline and Week 26
|
The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven negative-symptoms of schizophrenia.
Negative symptoms represent a diminution or loss of normal functions.
The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology).
Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
|
Baseline and Week 26
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26
Time Frame: Baseline and Week 26
|
The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.
A rating of 1 indicates to "normal, not at all ill" and a rating of 7 indicates "among the most extremely ill participants".
Higher scores indicate worsening.
Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
|
Baseline and Week 26
|
Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26
Time Frame: Baseline and Week 26
|
The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior.
The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains.
Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.
Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
|
Baseline and Week 26
|
Change From Baseline in Sleep Quality at Week 26
Time Frame: Baseline and Week 26
|
Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep.
Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: "very badly" to 100: "very well").
Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
|
Baseline and Week 26
|
Change From Baseline in Daytime Drowsiness at Week 26
Time Frame: Baseline and Week 26
|
Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep.
Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: "not at all" to 100:"all the time").
Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
|
Baseline and Week 26
|
Number of Participants Within Each Category of Patient Satisfaction Score
Time Frame: Baseline and Week 26
|
Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).
Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
|
Baseline and Week 26
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
August 8, 2012
First Submitted That Met QC Criteria
August 8, 2012
First Posted (Estimate)
August 10, 2012
Study Record Updates
Last Update Posted (Estimate)
May 5, 2014
Last Update Submitted That Met QC Criteria
April 17, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- 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
- CR013534
- R076477SCH3024 (Other Identifier: Janssen Pharmaceutica)
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 Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on Paliperidone ER
-
Watson PharmaceuticalsCompletedAnemia, Iron-Deficiency | Hemodialysis | Kidney Failure, ChronicUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedSchizophrenia | Schizoaffective Disorder | Schizophreniform Disorders
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedPsychotic Disorders | Schizophrenia | Bipolar DisorderUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Taiwan LtdCompleted
-
Janssen-Cilag S.p.A.Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Janssen Research & Development, LLCCompletedPsychotic Disorders | Schizophrenia | Schizophrenic Disorders | Dementia PraecoxUnited States, Belgium, Poland, Bulgaria, India, Romania, Russian Federation, Ukraine, Korea, Republic of, Estonia, Finland