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Completed

NCT Number: NCT01698216

Switching From Consta® to Sustenna® in Patients With Schizophrenia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Subjective Well-being Under Neuroleptic Treatment (SWN)

    Time frame: Change from Baseline in SWN score at 108 weeks

Secondary outcomes

  1. Korean Drug Attitude Inventory-10

    Time frame: Change from Baseline in score at 108 weeks

  2. Positive and Negative Syndrome Scale

    Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week

  3. Clinical Global Impression-Severity, Improvement

    Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week

  4. Personal and Social Performance Scale

    Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week

  5. Symptom Check List-90-Revised

    Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week

  6. Drug-Induced ExtraPyramidal Symptoms Scale

    Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week

  7. Liverpool University Neuroleptic Side Effect Rating Scale

    Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week

  8. Visual Analog Scale

    Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week

    injection site pain

  9. ECG

    Time frame: 8, 24, 48, 72, 108 week

    electrocardiogram

  10. blood pressure

    Time frame: 0,4,8,16,24,48,72,108 week

  11. Body weight

    Time frame: 0,4,8,16,24,48,72,108 week

  12. waist circumference

    Time frame: 0,4,8,16,24,48,72,108 week

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2012
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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