An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)
February 2, 2022 updated by: Organon and Co
A Randomized, Crossover Study Evaluating the Acceptability of Unflavored Asenapine and Raspberry Flavored Asenapine in Stable Subjects With A Psychotic Disorder
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 Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
174
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sequence 1
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.
|
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
|
|
Experimental: Sequence 2
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.
|
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
|
|
Experimental: Sequence 3
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.
|
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
|
|
Experimental: Sequence 4
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.
|
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
|
|
Experimental: Sequence 5
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.
|
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
|
|
Experimental: Sequence 6
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.
|
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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?""
Time Frame: After each dose (morning and evening of days 1 through 3)
|
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?"
Time Frame: After each dose (morning and evening of days 1 through 3)
|
After each dose (morning and evening of days 1 through 3)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
After each dose (morning and evening of days 1 through 3)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2005
Primary Completion (Actual)
October 15, 2005
Study Completion (Actual)
October 15, 2005
Study Registration Dates
First Submitted
April 8, 2009
First Submitted That Met QC Criteria
April 8, 2009
First Posted (Estimate)
April 9, 2009
Study Record Updates
Last Update Posted (Actual)
February 4, 2022
Last Update Submitted That Met QC Criteria
February 2, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P07010
- A7501024
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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