An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Crossover Study Evaluating the Acceptability of Unflavored Asenapine and Raspberry Flavored Asenapine in Stable Subjects With A Psychotic Disorder

Conditions
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Psychosis

Intervention / Treatment
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* Drug: Asenapine WHITE raspberry flavor (Treatment A)
* Drug: Asenapine RED raspberry flavor (Treatment B)
* Drug: Asenapine WHITE UNFLAVORED (Treatment C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are at least 18 years of age and of legal minimum age for trial participation; are a male, or a female who is not of childbearing potential are free from an acute exacerbation of psychosis for at least 3 months; have a current DSM-IV diagnosis of schizophrenia (paranoid, disorganized, catatonic, or undifferentiated subtype), or schizoaffective disorder; delusional disorder, major depressive disorder, or bipolar disorder, for whom chronic antipsychotic therapy is indicated; correctly identify 3 out of 4 basic flavors (bitter, sweet, salty, or sour) on a neutral taste paradigm; are receiving oral antipsychotic medication. Exclusion Criteria: an uncontrolled, unstable clinically significant medical condition clinically significant abnormal laboratory, vital sign, PE, or ECGs findings at Screening; previously experienced NMRB (also known as vasovagal reflex) or sensitivity for fainting; a positive serum pregnancy test at screening, or the intention to become pregnant within the next 30 days; a history of seizures; a history of neuromalignant syndrome; a current (past 6 months) substance abuse or dependence according to DSM-IV-TR criteria (excluding nicotine); an imminent risk of self-harm or harm to others; currently receiving a depot antipsychotic, such as fluphenazine decanoate, haloperidol decanoate, or Risperdal Consta, within at least 1 dosing cycle of Day-5; any impairment in taste functioning; receiving lithium or topiramate; judged by the principal investigator (PI) to be unable to reliably respond to the questionnaire based on clinically significant cognitive impairment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>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. | Drug: Asenapine WHITE raspberry flavor (Treatment A)<br>* Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine RED raspberry flavor (Treatment B)<br>* Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine WHITE UNFLAVORED (Treatment C)<br>* Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets<br>* Other names: SCH 900274;|
| Experimental: Sequence 2<br>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. | Drug: Asenapine WHITE raspberry flavor (Treatment A)<br>* Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine RED raspberry flavor (Treatment B)<br>* Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine WHITE UNFLAVORED (Treatment C)<br>* Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets<br>* Other names: SCH 900274;|
| Experimental: Sequence 3<br>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. | Drug: Asenapine WHITE raspberry flavor (Treatment A)<br>* Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine RED raspberry flavor (Treatment B)<br>* Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine WHITE UNFLAVORED (Treatment C)<br>* Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets<br>* Other names: SCH 900274;|
| Experimental: Sequence 4<br>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. | Drug: Asenapine WHITE raspberry flavor (Treatment A)<br>* Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine RED raspberry flavor (Treatment B)<br>* Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine WHITE UNFLAVORED (Treatment C)<br>* Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets<br>* Other names: SCH 900274;|
| Experimental: Sequence 5<br>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. | Drug: Asenapine WHITE raspberry flavor (Treatment A)<br>* Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine RED raspberry flavor (Treatment B)<br>* Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine WHITE UNFLAVORED (Treatment C)<br>* Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets<br>* Other names: SCH 900274;|
| Experimental: Sequence 6<br>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. | Drug: Asenapine WHITE raspberry flavor (Treatment A)<br>* Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine RED raspberry flavor (Treatment B)<br>* Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets<br>* Other names: SCH 900274;Drug: Asenapine WHITE UNFLAVORED (Treatment C)<br>* Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets<br>* Other names: SCH 900274;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) |