Switching From Consta® to Sustenna® in Patients With Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01698216
First received: September 27, 2012
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Subjective Well-being Under Neuroleptic Treatment (SWN) [ Time Frame: Change from Baseline in SWN score at 108 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Korean Drug Attitude Inventory-10 [ Time Frame: Change from Baseline in score at 108 weeks ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Severity, Improvement [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: No ]
  • Personal and Social Performance Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: No ]
  • Symptom Check List-90-Revised [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: No ]
  • Drug-Induced ExtraPyramidal Symptoms Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: Yes ]
  • Liverpool University Neuroleptic Side Effect Rating Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: Yes ]
  • Visual Analog Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: Yes ]
    injection site pain

  • ECG [ Time Frame: 8, 24, 48, 72, 108 week ] [ Designated as safety issue: Yes ]
    electrocardiogram

  • blood pressure [ Time Frame: 0,4,8,16,24,48,72,108 week ] [ Designated as safety issue: Yes ]
  • Body weight [ Time Frame: 0,4,8,16,24,48,72,108 week ] [ Designated as safety issue: Yes ]
  • waist circumference [ Time Frame: 0,4,8,16,24,48,72,108 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Consta Sustenna switching
The patients group who switched to paliperidone palmitate from risperidone long acting injection

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698216

Contacts
Contact: Hyun Jeong Lee, MD hjlee.np@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyun Jeong Lee, MD       hjlee.np@gmail.com   
Principal Investigator: Yong Min Ahn, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Yong Min Ahn, MD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Yong Min Ahn, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01698216     History of Changes
Other Study ID Numbers: Consta_Sustenna
Study First Received: September 27, 2012
Last Updated: December 5, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Paliperidone
Palmitate
switching
schizophrenia
subjective well-being

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 25, 2014