Schizophrenia Clinical Trial
Official title:
Effectiveness of Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients: A 8-week Open-label Prospective, Non-comparative Study
Verified date | April 2019 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is changing (improving), after initiating various doses of Paliperidone ER on schizophrenia patients.
Status | Completed |
Enrollment | 11 |
Est. completion date | November 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Dongguk University International Hospital | Goyang-si | |
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Johnson & Johnson |
Korea, Republic of,
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. — View Citation
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. — View Citation
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. Erratum in: Arch Gen Psychiatry 1998 Nov;55(11):1052. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MADRS(montgomery asberg depression rating scale) | 8 weeks | ||
Secondary | Positive and Negative Symptom Scale(PANSS) | 8 weeks | ||
Secondary | Clinical Global Impression-Schizophrenia-severity(CGI-SCH-S) | 8 weeks | ||
Secondary | Korean Drug Attitude Inventory-10 items (KDAI-10) | 8 weeks | ||
Secondary | Medication Satisfaction Questionnaire(MSQ) | 8 weeks | ||
Secondary | Clinician Rating Scale (CRS) | 8 weeks | ||
Secondary | Medication Adherence Rating Scale(MARS) | 8 weeks | ||
Secondary | Beck's Depression Inventory(BDI) | 8 weeks | ||
Secondary | Subjective Well-being Under Neuroleptic Treatment Scale(SWN) | 8 weeks | ||
Secondary | C-SSRS(Colombia-Suicide Severity Rating Scale) | 8 weeks | ||
Secondary | Clinical Laboratory Tests | 8 weeks | ||
Secondary | Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS) | 8 weeks |
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