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| ID | Type | Description | Link |
|---|---|---|---|
| PAL-KOR-9015 | Other Grant/Funding Number | Johnson and Johnson company |
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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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The purpose of this study is changing (improving), after initiating various doses of Paliperidone ER on schizophrenia patients.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paliperidone add on | Experimental | paliperidone add on |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paliperidone | Drug | paliperidone augmenting on ongoing medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| MADRS(montgomery asberg depression rating scale) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong Min Ahn, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguk University International Hospital | Goyang-si | 410-773 | South Korea | |||
| Seoul National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9510219 | Background | 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. | |
| 10435202 | 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. |
| Label | URL |
|---|---|
| study site | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 8 weeks |
| Medication Satisfaction Questionnaire(MSQ) | 8 weeks |
| Clinician Rating Scale (CRS) | 8 weeks |
| Medication Adherence Rating Scale(MARS) | 8 weeks |
| Beck's Depression Inventory(BDI) | 8 weeks |
| Subjective Well-being Under Neuroleptic Treatment Scale(SWN) | 8 weeks |
| C-SSRS(Colombia-Suicide Severity Rating Scale) | 8 weeks |
| Clinical Laboratory Tests | 8 weeks |
| Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS) | 8 weeks |
| Seoul |
| South Korea |
| 18854723 | 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. |
| D011743 |
| Pyrimidines |