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

NCT01399450 | Completed Phase 4 DMC

• 1 other identifier: PAL-KOR-9015
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizophrenia, depressive symptom, paliperidone

Outcome Measures

Primary Outcomes (1)

• MADRS(montgomery asberg depression rating scale)

  8 weeks

Secondary Outcomes (11)

• Positive and Negative Symptom Scale(PANSS)

  8 weeks

• Clinical Global Impression-Schizophrenia-severity(CGI-SCH-S)

  8 weeks

• Korean Drug Attitude Inventory-10 items (KDAI-10)

  8 weeks

• Medication Satisfaction Questionnaire(MSQ)

  8 weeks

• Clinician Rating Scale (CRS)

  8 weeks

Study Arms (1)

paliperidone add on

EXPERIMENTAL

paliperidone add on

Drug: paliperidone

Interventions

paliperidone DRUG

paliperidone augmenting on ongoing medication

Also known as: Invega®

paliperidone add on

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Johnson & Johnson: collaborator

Study Sites (2)

Dongguk University International Hospital

Goyang-si, 410-773, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (3)

• Tollefson GD, Sanger TM, Lu Y, Thieme ME. Depressive signs and symptoms in schizophrenia: a prospective blinded trial of olanzapine and haloperidol. Arch Gen Psychiatry. 1998 Mar;55(3):250-8. doi: 10.1001/archpsyc.55.3.250.

  PMID: 9510219 BACKGROUND

• Tollefson GD, Andersen SW, Tran PV. The course of depressive symptoms in predicting relapse in schizophrenia: a double-blind, randomized comparison of olanzapine and risperidone. Biol Psychiatry. 1999 Aug 1;46(3):365-73. doi: 10.1016/s0006-3223(99)00049-9.

  PMID: 10435202 BACKGROUND

• Emsley R, Berwaerts J, Eerdekens M, Kramer M, Lane R, Lim P, Hough D, Palumbo J. Efficacy and safety of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 52-week open-label studies. Int Clin Psychopharmacol. 2008 Nov;23(6):343-56. doi: 10.1097/YIC.0b013e328314e1f3.

  PMID: 18854723 BACKGROUND

Related Links

• study site

MeSH Terms

Conditions

Schizophrenia; Depression

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

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: July 20, 2011
• First Posted: July 21, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

KR (2)