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This study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine |
|
| 2A | Placebo Comparator | Double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35 |
|
| 2B | Placebo Comparator | Double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cariprazine | Drug | Patients meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate-corrected QT interval (QTc) | The effects of a therapeutic dosage (9 mg/day) and a supratherapeutic dosage (18 mg/day) of cariprazine on cardiac repolarization as determined by heart-rate-corrected QT intervals will be assessed on Day 20 and Day 34, respectively. The assay sensitivity of moxifloxacin 400 mg/day will be assessed on Day 6 and Day 35. | 35 days of double-blind treatment, up to 56 days total. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suneeta Ahuja, PhD | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 001 | Glendale | California | 91206 | United States | ||
| Forest Investigative Site 004 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C533287 | cariprazine |
| D018967 | Risperidone |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Risperidone/Moxifloxacin | Drug | Patients randomized to Group 2A will receive double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35. |
|
| Risperidone/Moxifloxacin | Drug | Patients randomized to Group 2B will receive double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35. |
|
| Long Beach |
| California |
| 90806 |
| United States |
| Forest Investigative Site 002 | Willingboro | New Jersey | 08046 | United States |
| Forest Investigative Site 003 | Houston | Texas | 77008 | United States |
| D024841 |
| Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |