NCT01860781

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

4.3 years

First QC Date

May 21, 2013

Last Update Submit

December 6, 2015

Conditions

Schizophrenia

Keywords

SchizophreniaInjectionSwitchPaliperidonerefractory, chronic akathisia, poor complianc

Outcome Measures

Primary Outcomes (1)

  • CGI-S,I: Clinical Global Impression-Severity, Improvement

    24 weeks

Secondary Outcomes (7)

  • PANSS: Positive and Negative Syndrome Scale

    24 weeks

  • CRS: Clinician Rating Scale

    24 weeks

  • KDAI-10: Korean Drug Attitude Inventory-10

    24 weeks

  • SWN: Subjective Well-being Under Neuroleptic Treatment

    24 weeks

  • DIEPSS: Drug-Induced ExtraPyramidal Symptoms Sclae

    24 weeks

  • +2 more secondary outcomes

Study Arms (1)

paliperidone palmitate

EXPERIMENTAL

paliperidone palmitate

Drug: paliperidone palmitate

Interventions

paliperidone palmitateDRUG

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

Also known as: paliperidone palmitate(sustenna)
paliperidone palmitate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Yong Min Ahn, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 23, 2013

Study Start

August 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

KR(1)