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

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. Identifier: NCT01399450
Recruitment Status : Completed
First Posted : July 21, 2011
Last Update Posted : April 9, 2019
Johnson & Johnson
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital

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

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

Detailed Description:
In this study, investigators are going to examine the effectiveness of Paliperidone ER on depressive symptoms toward schizophrenia patients who are previously unresponsive to other oral antipsychotics. In addition, the relationship between the change of depressive symptoms and adherence will be studied. Even though this study has a limitation of being designed as an open-labelled clinical study, it would be useful for clinicians because this study examines the influences toward adherence related to various factors and the changes of depressive symptoms related to switching to Paliperidone ER, which is well-proven medication.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients: A 8-week Open-label Prospective, Non-comparative Study
Study Start Date : August 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: paliperidone add on
paliperidone add on
Drug: paliperidone
paliperidone augmenting on ongoing medication
Other Name: Invega®

Primary Outcome Measures :
  1. MADRS(montgomery asberg depression rating scale) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Positive and Negative Symptom Scale(PANSS) [ Time Frame: 8 weeks ]
  2. Clinical Global Impression-Schizophrenia-severity(CGI-SCH-S) [ Time Frame: 8 weeks ]
  3. Korean Drug Attitude Inventory-10 items (KDAI-10) [ Time Frame: 8 weeks ]
  4. Medication Satisfaction Questionnaire(MSQ) [ Time Frame: 8 weeks ]
  5. Clinician Rating Scale (CRS) [ Time Frame: 8 weeks ]
  6. Medication Adherence Rating Scale(MARS) [ Time Frame: 8 weeks ]
  7. Beck's Depression Inventory(BDI) [ Time Frame: 8 weeks ]
  8. Subjective Well-being Under Neuroleptic Treatment Scale(SWN) [ Time Frame: 8 weeks ]
  9. C-SSRS(Colombia-Suicide Severity Rating Scale) [ Time Frame: 8 weeks ]
  10. Clinical Laboratory Tests [ Time Frame: 8 weeks ]
  11. Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS) [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • 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.

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT01399450

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Korea, Republic of
Dongguk University International Hospital
Goyang-si, Korea, Republic of, 410-773
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Johnson & Johnson
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Principal Investigator: Yong Min Ahn, MD, PhD Seoul National University Hospital

Additional Information:
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Responsible Party: Yong Min Ahn, Professor, Seoul National University Hospital Identifier: NCT01399450     History of Changes
Other Study ID Numbers: PAL-KOR-9015
PAL-KOR-9015 ( Other Grant/Funding Number: Johnson and Johnson company )
First Posted: July 21, 2011    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

Keywords provided by Yong Min Ahn, Seoul National University Hospital:
Schizophrenia, depressive symptom, paliperidone

Additional relevant MeSH terms:
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Paliperidone Palmitate
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Behavioral Symptoms
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