Back to resultsAn Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)
Primary Purpose
Psychosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Asenapine WHITE raspberry flavor (Treatment A)
Asenapine RED raspberry flavor (Treatment B)
Asenapine WHITE UNFLAVORED (Treatment C)
Sponsored by
About this trial
This is an interventional other trial for Psychosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Sequence 1
Sequence 2
Sequence 3
Sequence 4
Sequence 5
Sequence 6
Arm Description
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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?""
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?"
Secondary Outcome Measures
Responses on the following question: "How acceptable was the taste of the tablet?"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00878462
Brief Title
An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)
Official Title
A Randomized, Crossover Study Evaluating the Acceptability of Unflavored Asenapine and Raspberry Flavored Asenapine in Stable Subjects With A Psychotic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2005 (Actual)
Primary Completion Date
October 15, 2005 (Actual)
Study Completion Date
October 15, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence 5
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence 6
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Asenapine WHITE raspberry flavor (Treatment A)
Other Intervention Name(s)
Saphris, Org 5222, SCH 900274
Intervention Description
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Intervention Type
Drug
Intervention Name(s)
Asenapine RED raspberry flavor (Treatment B)
Other Intervention Name(s)
Saphris, Org 5222, SCH 900274
Intervention Description
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Intervention Type
Drug
Intervention Name(s)
Asenapine WHITE UNFLAVORED (Treatment C)
Other Intervention Name(s)
Saphris, Org 5222, SCH 900274
Intervention Description
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Primary Outcome Measure Information:
Title
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?""
Time Frame
After each dose (morning and evening of days 1 through 3)
Title
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?"
Time Frame
After each dose (morning and evening of days 1 through 3)
Secondary Outcome Measure Information:
Title
Responses on the following question: "How acceptable was the taste of the tablet?"
Time Frame
After each dose (morning and evening of days 1 through 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)
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