The Effect of Paliperidone Palmitate in Schizophrenia (sustenna)

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: paliperidone palmitate

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: paliperidone palmitate	Drug: paliperidone palmitate; paliperidone palmitate 150mgeq(1 day), 100mgeq(8days), 75mg(monthly); Other Names: paliperidone palmitate(sustenna)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CGI-S,I: Clinical Global Impression-Severity, Improvement	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
injection site pain -VAS: Visual Analog Scale	24 weeks
LUNSERS: Liverpool University Neuroleptic Side Effect Rating Scale	24 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (ESTIMATE): May 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 8, 2015
• Last Update Submitted That Met QC Criteria: December 6, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Schizophrenia; Paliperidone; Injection; Switch; refractory, chronic akathisia, poor complianc
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate
• Other Study ID Numbers: R092670-SCH-4008