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Completed

NCT Number: NCT01860781

The Effect of Paliperidone Palmitate in Schizophrenia

The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within three different group of 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

Seoul National University Hospital

Seoul, South Korea

About this study

In this study, the investigators are going to examine the effectiveness of paliperidone palmitate after changing from other antipsychotics. This study design is a Prospective Naturalistic Case Series Study. The effectiveness of paliperidone would be compared within three different groups of schizophrenia. Investigators would also assess the safety during 24 weeks follow up period.

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.
  • PANSSS total score <120
  • each Score of disorganized thought, paranoia hallucinatory behavior, abnormal tbought contests < 16
  • three different groups ( other antipsychotics refractory schizophrenia patitents : CGI> 4 chronic akathisia : DIEPSS overall severity >1, at least 1 month lasting symptoms poor compliance schizophrenia : CRS <3)
  • 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 prescription
  • History of NMS(Neuroleptic malignant syndrome)
  • Allergic reaction or hypersensitive reaction of risperidone or paliperidone ER
  • clozapine medication within 1 month before screening
  • SSRI, MAOI, TCA medication within 2 months
  • Lithium, valproic acid, carbamazepine, topiramate, lamotrigine medication starting within 2 months
  • 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 or previous history of drug depedence according to DSM-IV
  • Pregnant or breast-feeding female patient
  • Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion
  • history of cardiac disease, which is related to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia)
  • 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

Paliperidone palmitate

Drug

paliperidone palmitate 150mgeq(1 day), 100mgeq(8days), 75mg(monthly)

Other names: paliperidone palmitate(sustenna)

Primary outcomes

  1. CGI-S,I: Clinical Global Impression-Severity, Improvement

    Time frame: 24 weeks

Secondary outcomes

  1. PANSS: Positive and Negative Syndrome Scale

    Time frame: 24 weeks

  2. CRS: Clinician Rating Scale

    Time frame: 24 weeks

  3. KDAI-10: Korean Drug Attitude Inventory-10

    Time frame: 24 weeks

  4. SWN: Subjective Well-being Under Neuroleptic Treatment

    Time frame: 24 weeks

  5. DIEPSS: Drug-Induced ExtraPyramidal Symptoms Sclae

    Time frame: 24 weeks

  6. injection site pain -VAS: Visual Analog Scale

    Time frame: 24 weeks

  7. LUNSERS: Liverpool University Neuroleptic Side Effect Rating Scale

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Effect of Paliperidone Palmitate in Schizophrenia: A Prospective Naturalistic Case Series Study

Acronym: sustenna

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 23, 2013
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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