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| ID | Type | Description | Link |
|---|---|---|---|
| R092670SCH4003 |
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This study was stopped due to an internal reconsideration of priorities of the product portfolio.
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The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.
The primary objective of this study will be to compare paliperidone palmitate treatment with the randomly assigned oral antipsychotic treatment in delaying time to treatment failure over 12 months in subjects diagnosed with schizophrenia who were recently discharged from an inpatient psychiatric hospital. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for twelve months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months |
|
| 002 | Active Comparator | olanzapine flexible dosing as prescribed by the study doctor for 12 months |
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| 003 | Active Comparator | paliperidone flexible dosing as prescribed by the study doctor for 12 months |
|
| 004 | Active Comparator | aripiprazole flexible dosing as prescribed by the study doctor for 12 months |
|
| 005 | Active Comparator | haloperidole flexible dosing as prescribed by the study doctor for 12 months |
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| 006 | Active Comparator | perphenazine flexible dosing as prescribed by the study doctor for 12 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paliperidone palmitate | Drug | 78, 117, 156, or 234 mg monthly injection for 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Impression-Severity score | Up to 12 months | |
| Change in Global Assessment of Functionality score | Up to 12 months | |
| Change in Medication Satisfaction Questionnaire score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial | Ortho-McNeil Janssen Scientific Affairs, LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38958149 | Derived | Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2. |
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|
| 007 | Active Comparator | quetiapine flexible dosing as prescribed by the study doctor for 12 months |
|
| 008 | Active Comparator | risperidone flexible dosing as prescribed by the study doctor for 12 months |
|
| risperidone |
| Drug |
flexible dosing as prescribed by the study doctor for 12 months |
|
| olanzapine | Drug | flexible dosing as prescribed by the study doctor for 12 months |
|
| aripiprazole | Drug | flexible dosing as prescribed by the study doctor for 12 months |
|
| haloperidole | Drug | flexible dosing as prescribed by the study doctor for 12 months |
|
| quetiapine | Drug | flexible dosing as prescribed by the study doctor for 12 months |
|
| perphenazine | Drug | flexible dosing as prescribed by the study doctor for 12 months |
|
| paliperidone | Drug | flexible dosing as prescribed by the study doctor for 12 months |
|
| Up to 12 months |
| Proportion of subjects with at least one psychiatric hospitalization | Up to 12 months |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| D018967 | Risperidone |
| D000077152 | Olanzapine |
| D000068180 | Aripiprazole |
| D000069348 | Quetiapine Fumarate |
| D010546 | Perphenazine |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011744 | Pyrimidinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010879 | Piperazines |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D010640 | Phenothiazines |
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