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Completed

NCT Number: NCT01399450

Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients

The purpose of this study is changing (improving), after initiating various doses of Paliperidone ER on schizophrenia patients.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dongguk University International Hospital, Goyang-si, South Korea

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About this study

In this study, investigators are going to examine the effectiveness of Paliperidone ER on depressive symptoms toward schizophrenia patients who are previously unresponsive to other oral antipsychotics. In addition, the relationship between the change of depressive symptoms and adherence will be studied. Even though this study has a limitation of being designed as an open-labelled clinical study, it would be useful for clinicians because this study examines the influences toward adherence related to various factors and the changes of depressive symptoms related to switching to Paliperidone ER, which is well-proven medication.

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.
  • Patient who need initiation of new antipsychotics due to newly-development or recurrence of acute psychosis
  • MADRS≥16
  • 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

  • Past history of NMS.
  • Allergy or hypersensitivity to Risperidone or Paliperidone ER.
  • History of using clozapine within 1 month before screening.
  • 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.
  • History of severe gastrointestinal obstruction(pathologic or iatrogenic) or incapacity to swallow the drug form(it is not allowed to chew, divide, dissolve or make powder of clinical trial medication due to the possibility of influence on pharmacokinetics)
  • 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
  • Patients who take QT prolonging drugs or have
  • Pregnant or breast-feeding female patient.
  • History of participating to other investigational drug trial within 1month prior to screening.
  • History of taking of long-acting antipsychotics injection within 3month before 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

Paliperidone

Drug

paliperidone augmenting on ongoing medication

Other names: Invega®

Primary outcomes

  1. MADRS(montgomery asberg depression rating scale)

    Time frame: 8 weeks

Secondary outcomes

  1. Positive and Negative Symptom Scale(PANSS)

    Time frame: 8 weeks

  2. Clinical Global Impression-Schizophrenia-severity(CGI-SCH-S)

    Time frame: 8 weeks

  3. Korean Drug Attitude Inventory-10 items (KDAI-10)

    Time frame: 8 weeks

  4. Medication Satisfaction Questionnaire(MSQ)

    Time frame: 8 weeks

  5. Clinician Rating Scale (CRS)

    Time frame: 8 weeks

  6. Medication Adherence Rating Scale(MARS)

    Time frame: 8 weeks

  7. Beck's Depression Inventory(BDI)

    Time frame: 8 weeks

  8. Subjective Well-being Under Neuroleptic Treatment Scale(SWN)

    Time frame: 8 weeks

  9. C-SSRS(Colombia-Suicide Severity Rating Scale)

    Time frame: 8 weeks

  10. Clinical Laboratory Tests

    Time frame: 8 weeks

  11. Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS)

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

Effectiveness of Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients: A 8-week Open-label Prospective, Non-comparative Study

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jul 21, 2011
Registry last updated
Apr 9, 2019

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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