A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophrenia

October 24, 2024 updated by: Janssen Research & Development, LLC

Safety, Tolerability, and Treatment Response of Paliperidone Palmitate in Subjects With Schizophrenia When Switching From Oral Antipsychotics

The purpose of the study is to evaluate the safety, tolerability and treatment response of paliperidone palmitate administered as once-monthly injections to patients with schizophrenia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is an 18-month, single-group, open-label (name of study drug is known to patients), multicenter study to evaluate the safety, tolerability and treatment response of paliperidone palmitate administered as once-monthly injections to patients with schizophrenia who previously received treatment with oral antipsychotic medications. A target of 587 patients (inpatients or outpatients) with schizophrenia will be enrolled in the study and will receive, without cost, injections of study drug (paliperidone palmitate) on Days 1, 8, 38, and thereafter at one-month intervals up to 18 months. Enrollment in the study will be limited to patients who are diagnosed with schizophrenia within the past 5 years. The study will consist of a screening period of up to 5 days before treatment, an 18-month treatment period, and an end-of-study or early withdrawal visit approximately 30 days after the last injection of study drug. During the screening period (after patients have provided signed informed consent to participate in the study), information will be collected regarding the patients medical and psychiatric history, demographics (age and race), current symptoms of the patients schizophrenia, and whether or not the patient would like to sign an additional informed consent form to participate in the pharmacogenomic (the study of how genes affect a person's response to drugs) component of the study that involves the collection of one 10 ml blood sample (equivalent to about 2 teaspoons of blood). During screening, entry criteria for the study will be reviewed and a physical examination performed. Patients will also be asked questions about the types of healthcare resources (institutionalizations/hospitalizations, emergency room visits, etc) they utilized during the previous 12 months however, this information is optional and its collection will depend upon the availability of the data. Patients who are currently receiving treatment with any oral antipsychotic medication must discontinue the use of the medication by Day 1 of the study. If the patient was receiving a high dose of an antipsychotic medication or was also receiving an anticholinergic medication (a drug that prevents involuntary muscle movements associated with the use of antipsychotic drugs in the treatment of schizophrenia), the investigator may decide to have the patients dose of antipsychotic (and/or anticholinergic) medication tapered (gradually reduced) to discontinuation beginning on Day 1. The patients time to taper-off the previous antipsychotic and/or anticholinergic medications will depend on the dose of the medication. Patients receiving anxiolytics (anti-anxiety drugs), mood stabilizers, anticholinergics, or antidepressants greater than 4 weeks before the screening visit will be allowed to continue taking these drugs. Upon meeting the entry criteria for the study, patients will receive a total of 19 intramuscular (IM) injections of paliperidone palmitate during the 18-month treatment period as follows: 150 mg equivalent (eq) on Day 1, 100 mg eq on Day 8, 75 mg eq on Day 38, and paliperidone palmitate injections of 50, 75, 100, or 150 mg eq once monthly on Days 68, 98, 128, 158, 188, 218, 248, 278, 308, 338, 368, 398, 428, 458, 488 and 518. Depending on the patients ability to tolerate a dose paliperidone palmitate, doses may be adjusted higher or lower every 30 days per the clinicians judgment within the dose range of 50 to 150 mg eq. If the patient reports any signs or symptoms of worsening of schizophrenia, the investigator may prescribe a rescue medication (quick-relief or fast-acting medications that usually work right away to relieve symptoms) such as lorazepam (an antianxiety drug) to control agitation, irritability, restlessness, and hostility. The investigator may also prescribe an anticholinergic medication to treat involuntary movement disorders if observed in patients. All prescription and over-the-counter medications taken by patients during the study are to be reported. At the end of the 18-month treatment period, all patients will complete an end-of-study visit (or early withdrawal visit for patients who do not complete the study) to have a physical examination performed, laboratory tests (including a urine pregnancy test for women of childbearing potential) performed, vital signs measured, and information collected regarding the occurrence of adverse events and the use of medications other than study drug from the time of the previous study visit to the end-of-study (or early withdrawal visit). The primary objective of the study is to evaluate safety, tolerability and treatment response of once-monthly injections of paliperidone palmitate measured by the use of a Positive And Negative Symptom Scale (PANSS). The safety and tolerability of once-monthly injections of paliperidone palmitate administered to patients with schizophrenia will be evaluated during the study by monitoring adverse events, findings from clinical laboratory tests (serum chemistry including lipids), vital sign measurements (blood pressure, pulse rate, and weight), physical examinations, and movement disorder evaluations using the Extrapyramidal Symptom Rating Scale [ESRS-A]). All clinically significant abnormalities in patients that persist at the end of the study will be followed by the Investigator until resolution or until a clinically stable endpoint is reached. Treatment response will be evaluated 5 times during the study (Visits 2, 4, 6, 8 and 10) by findings obtained from the PANSS (a 30-item questionnaire that is administered to the patient by a qualified person [ie, rater] to measure the presence/absence and severity of positive and negative symptoms of schizophrenia. In addition to the safety, tolerability, and treatment response data collected, patients who volunteer to participate in the pharmacogenomic component of the study will have one 10 ml sample of blood collected at on Days of Visit 2. If a replacement blood sample is needed for the pharmacogenomic component of the study, the patient will need to sign an additional informed consent form. Patients will receive a paliperidone palmitate intramuscular (IM) injection of 150 mg equivalent (eq) on Day 1, 100 mg eq on Day 8, and 75 mg eq on Day 38.Thereafter, patients will receive once monthly IM injections of 50, 75, 100, or 150 mg eq of paliperidone palmitate. Doses may be adjusted every 30 days per the clinician's judgment within the dose range of 50 to 150 mg eq.Patients will receive a total of 19 injections of study drug over an 18-month treatment period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
546

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Dandenong, Australia
      • Elizabeth Vale, Australia
      • Epping, Australia
      • Frankston, Australia
      • Glenside, Australia
      • Heidelberg, Australia
      • Melbourne, Australia
      • Prahran, Australia
      • Westmead, Australia
  • China
      • Beijing, China
      • Guangzhou, China
      • Nanjing, China
      • Shanghai, China
      • Xian, China
  • Hong Kong
      • Hong Kong, Hong Kong
  • Korea, Republic of
      • Busan, Korea, Republic of
      • Daegu, Korea, Republic of
      • Daejeon, Korea, Republic of
      • Gwangju-Si, Korea, Republic of
      • Gyeonggi-Do, Korea, Republic of
      • Incheon, Korea, Republic of
      • Seoul, Korea, Republic of
  • Malaysia
      • Johor Bahru, Malaysia
      • Kota Bharu, Malaysia
      • Kota Kinabalu, Malaysia
      • Kuala Lumpur, Malaysia
      • Kuala Lumpur N/A, Malaysia
      • Kuching, Malaysia
      • Tanjong Rambutan, Malaysia
      • Terengganu, Malaysia
  • New Zealand
      • Auckland, New Zealand
  • Philippines
      • Pasig, Philippines
      • Pasig National Capitol Region, Philippines
  • Taiwan
      • Changhua County, Taiwan
      • Kaohsiung, Taiwan
      • Taichung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
  • Thailand
      • Bangkok, Thailand
      • Khon Kaen, Thailand
      • Songkhla, Thailand
      • Ubon Ratchathani, Thailand

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent to participate in the study obtained
  • Signed informed consent to participate in the optional pharmacogenomic component of the study obtained (refusal to give consent for the pharmacogenomic component of the study does not exclude a patient from participation in the clinical study)
  • Confirmation of diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) within 5 years prior to screening
  • Patient is willing and able to fill out self-administered questionnaires during the study
  • confirmation that patient has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time before enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication

Exclusion Criteria:

  • The patient's psychiatric diagnosis is due to the direct pharmacological effects of a drug of abuse substance or medication, or is due to a general medical condition (eg, clinically notable hypothyroidism)
  • The patient is treatment resistant in the judgment of the investigator
  • The patient meets the DSM-IV definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry
  • The patient has a previously defined hypersensitivity (anaphylaxis-type reaction) to risperidone or paliperidone or excipients
  • The patient has received treatment with a long-acting injectable antipsychotic within 3 injection cycles prior to baseline, received clozapine within 3 months prior to screening, received treatment with other investigational agents within 30 days of the screening visit, has participated in more than one investigational drug study in the past 12 months, or has planned use of other investigational drugs during the time frame of the study
  • History or current symptoms of tardive dyskinesia, history of neuroleptic malignant syndrome, or evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in the past 6 months

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Paliperidone palmitate
Drug: Paliperidone palmitate
One intramuscular (IM) injection of paliperidone palmitate 150 mg equivalent (eq.) on Day 1, 100 mg eq. on Day 8, and 75 mg eq. on Day 38. Thereafter, one IM injection of paliperidone palmitate 50, 75, 100, or 150 mg eq. once monthly. Doses may be adjusted every 30 days per the clinician's judgment within the dose range of 50 to 150 mg eq.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Treatment response will be evaluated by findings from the PANSS-a 30-item questionnaire that is administered to the patient by a qualified person (ie, rater) to measure the presence/absence and severity of positive and negative symptoms of schizophrenia
Time Frame: Treatment response will be evaluated at 5 times during the study (Day 1, day 38, day 98, day 188, day 368 and day 548).
Treatment response will be evaluated at 5 times during the study (Day 1, day 38, day 98, day 188, day 368 and day 548).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The change in personal and social performance (PSP) score and evolution of ratio of mild degree dysfunction, varying degree difficulty, and poor level function based on PSP score after switch to paliperidone palmitate
Time Frame: 5 visits (Day 1, day 38, day 188, day 368 and day 548)
5 visits (Day 1, day 38, day 188, day 368 and day 548)
The rate of discontinuation, the rate of patients hospitalized, the total number and mean duration of institutionalizations, the overall score in global severity of illness, symptom remission, and medication satisfaction questionnaire findings
Time Frame: 9 visits (Day 1, day 8, day 38, day 98, day 188, day 278, day 368, day458 and day 548)
9 visits (Day 1, day 8, day 38, day 98, day 188, day 278, day 368, day458 and day 548)
The changes in total PANSS score and PANSS sub-domains/symptom factors
Time Frame: 5 visits (Day 1, day 38, day 188, day 368 and day 548).
5 visits (Day 1, day 38, day 188, day 368 and day 548).
Safety measures (laboratories, adverse events, ESRS-A)
Time Frame: Laboratories (Days 1 and 548; Adverse events (Days 1, 8,38,68,98,128,158,188,218,248, 278, 308, 338, 368, 398, 448, 458, 488, 518 and 548) ESRS-A (Days 1, 8, 38, 98, 188, 278, 368, 458 and 548)
Laboratories (Days 1 and 548; Adverse events (Days 1, 8,38,68,98,128,158,188,218,248, 278, 308, 338, 368, 398, 448, 458, 488, 518 and 548) ESRS-A (Days 1, 8, 38, 98, 188, 278, 368, 458 and 548)
Assessment of healthcare resource utilization
Time Frame: 7 visits (Day -7, Day 98, day 188, day 278, day 368, day 458 and day 548)
7 visits (Day -7, Day 98, day 188, day 278, day 368, day 458 and day 548)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR016522
  • R092670SCH3009 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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