Switching From Consta® to Sustenna® in Patients With Schizophrenia

December 7, 2015 updated by: Yong Min Ahn, Seoul National University Hospital

Switching From Risperidone Long Acting Injection (Consta®) to Paliperidone Palmitate (Sustenna®) in Patients With Schizophrenia and Its Influence on Subjective Well-Being: A Prospective Observational Study

The aim of this study is observation of effectiveness and side effect of patients with schizophrenia who will switch the antipsychotics from risperidone long acting injection to paliperidone palmitate.

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.

Detailed Description

In this study, investigators are going to enroll the patients who will switch the risperidone long acting injection to paliperidone palmitate. And investigators will examine the effectiveness and side effect of paliperidone palmitate. In addition, effectiveness and side effect related variables will be studied.

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.
Observational

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.
50

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

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with schizophrenia who would be switched to Paliperidone Palmitate from Risperidone Long Acting Injection

Description

Inclusion Criteria:

  • Age: 18 ~ 65
  • Patient with schizophrenia according to DSM-IV criteria
  • Patient have signed on the informed consent, and well understood the objective and procedure of this study.
  • Maintenance therapy more than 6 months with Risperidone Long Acting Injection monotherapy or other with concomitant antipsychotics, and stable dose of Risperidone Long Acting Injection was maintained 8 weeks more. The stable dose of other antipsychotics has been maintained 8 months and more.
  • Patient wants to switch antipsychotics to Paliperidone Palmitate.
  • PANSS total score ≤ 80
  • Each score of conceptual disorganization(P2), hallucinatory behavior(P3), Suspiciousness/persecution(P6), unusual thought content(G9)in PANSS ≤ 4
  • Competent patient who is manage to answer the questionnaires.
  • In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.

Exclusion Criteria:

  • No history of antipsychotics use.
  • Past history of NMS.
  • Allergy or hypersensitivity to Risperidone or Paliperidone ER.
  • Concomitant antipsychotics was oral Risperidone or Paliperidone ER.
  • Initiating or dose-changing of SSRI, MAOI, TCA within 2 months(maintenance is allowed if those have been stable for at least 30days prior to study entry and would not be any dose changes during the study)
  • Initiating of Lithium, Valproic acid, Carbamazepine, Topiramate, Lamotrigine or other mood stabilizer within 2months (maintenance is allowed).
  • Patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion.
  • Current substance dependence(DSM-IV) or past history of dependence (more than 6months)
  • Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion.
  • History of cardiac disease which predispose to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia) or current medication of QT prolonging drugs
  • Pregnant or breast-feeding female patient.
  • History of participating to other investigational drug trial within 1month prior to screening.
  • Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Consta Sustenna switching
The patients group who switched to paliperidone palmitate from risperidone long acting injection

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
Subjective Well-being Under Neuroleptic Treatment (SWN)
Time Frame: Change from Baseline in SWN score at 108 weeks
Change from Baseline in SWN score at 108 weeks

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
Measure Description
Time Frame
Korean Drug Attitude Inventory-10
Time Frame: Change from Baseline in score at 108 weeks
Change from Baseline in score at 108 weeks
Positive and Negative Syndrome Scale
Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
0,4,8,16,24,36,48,60,72,84,96,108 week
Clinical Global Impression-Severity, Improvement
Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
0,4,8,16,24,36,48,60,72,84,96,108 week
Personal and Social Performance Scale
Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
0,4,8,16,24,36,48,60,72,84,96,108 week
Symptom Check List-90-Revised
Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
0,4,8,16,24,36,48,60,72,84,96,108 week
Drug-Induced ExtraPyramidal Symptoms Scale
Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
0,4,8,16,24,36,48,60,72,84,96,108 week
Liverpool University Neuroleptic Side Effect Rating Scale
Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
0,4,8,16,24,36,48,60,72,84,96,108 week
Visual Analog Scale
Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
injection site pain
0,4,8,16,24,36,48,60,72,84,96,108 week
ECG
Time Frame: 8, 24, 48, 72, 108 week
electrocardiogram
8, 24, 48, 72, 108 week
blood pressure
Time Frame: 0,4,8,16,24,48,72,108 week
0,4,8,16,24,48,72,108 week
Body weight
Time Frame: 0,4,8,16,24,48,72,108 week
0,4,8,16,24,48,72,108 week
waist circumference
Time Frame: 0,4,8,16,24,48,72,108 week
0,4,8,16,24,48,72,108 week

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.
Seoul National University Hospital

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.
  • Principal Investigator: Yong Min Ahn, MD, Seoul National University Hospital

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

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.
December 1, 2011

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 1, 2015

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 1, 2015

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).
September 27, 2012

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.
September 28, 2012

First Posted (ESTIMATE)

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.
October 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

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.
December 8, 2015

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.
December 7, 2015

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.
December 1, 2015

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.
  • Consta_Sustenna

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.

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