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| ID | Type | Description | Link |
|---|---|---|---|
| A7501024 |
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This trial was a randomized trial to determine a patient's acceptability of unflavored antipsychotic medication compared to raspberry flavored antipsychotic medication. Patients received 6 total doses of study drug (2 doses of each asenapine formulation) over 3 consecutive days: 2 different formulations each day, 1 in the morning and 1 in the evening. The formulations were: white unflavored, white raspberry flavored, and red raspberry flavored. Patients were given a questionnaire following each dose of study medication (one questionnaire twice per day for 3 days) to measure how acceptable each formulation was.
Study drug was administered according to a random selected sequence schedule with 2 constraints: Subjects did not receive consecutive doses of the same formulation, and each formulation was given once in the morning and once in the evening over the course of the 3-day treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Subjects randomly assigned to this sequence receive in order: Treatment A, C, B, A, C, B. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
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| Sequence 2 | Experimental | Subjects randomly assigned to this sequence receive in order: Treatment A, B, C, A, B, C. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
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| Sequence 3 | Experimental | Subjects randomly assigned to this sequence receive in order: Treatment B, C, A, B, C, A. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
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| Sequence 4 | Experimental | Subjects randomly assigned to this sequence receive in order: Treatment B, A, C, B, A, C. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine WHITE raspberry flavor (Treatment A) | Drug | Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| The response to the question: "How likely would you be to take this medication for at least 1 year if your doctor continued to prescribe it to you and it worked well?"" | After each dose (morning and evening of days 1 through 3) | |
| The response on the following question: "Considering your total impression of this tablet, like the look, the taste and the feel of the tablet, how acceptable is this tablet to you?" | After each dose (morning and evening of days 1 through 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Responses on the following question: "How acceptable was the taste of the tablet?" | After each dose (morning and evening of days 1 through 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Sequence 5 | Experimental | Subjects randomly assigned to this sequence receive in order: Treatment C, B, A, C, B, A. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
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| Sequence 6 | Experimental | Subjects randomly assigned to this sequence receive in order: Treatment C, A, B, C, A, B. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
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| Asenapine RED raspberry flavor (Treatment B) | Drug | Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets |
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| Asenapine WHITE UNFLAVORED (Treatment C) | Drug | Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522667 | asenapine |
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