Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Paliperidone Palmitate in Schizophrenia (sustenna)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01860781
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: paliperidone palmitate Phase 4

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Paliperidone Palmitate in Schizophrenia: A Prospective Naturalistic Case Series Study
Study Start Date : August 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: paliperidone palmitate
paliperidone palmitate
Drug: paliperidone palmitate
paliperidone palmitate 150mgeq(1 day), 100mgeq(8days), 75mg(monthly)
Other Name: paliperidone palmitate(sustenna)




Primary Outcome Measures :
  1. CGI-S,I: Clinical Global Impression-Severity, Improvement [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860781


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yong Min Ahn, MD, PhD Seoul National University Hospital

Layout table for additonal information
Responsible Party: Yong Min Ahn, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01860781     History of Changes
Other Study ID Numbers: R092670-SCH-4008
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Yong Min Ahn, Seoul National University Hospital:
Schizophrenia
Injection
Switch
Paliperidone
refractory, chronic akathisia, poor complianc

Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents