An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (A7501024)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00878462
First received: April 8, 2009
Last updated: October 2, 2009
Last verified: October 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psychosis |
Drug: Asenapine WHITE raspberry flavor (Treatment A) Drug: Asenapine RED raspberry flavor (Treatment B) Drug: Asenapine WHITE UNFLAVORED (Treatment C) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Randomized, Crossover Study Evaluating the Acceptability of Unflavored Asenapine and Raspberry Flavored Asenapine in Stable Subjects With A Psychotic Disorder |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
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?"" [ Time Frame: After each dose (morning and evening of days 1 through 3) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
| Enrollment: | 174 |
| Study Start Date: | June 2005 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
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.
|
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
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.
|
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
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.
|
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
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.
|
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
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.
|
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00878462 History of Changes |
| Other Study ID Numbers: | A7501024 |
| Study First Received: | April 8, 2009 |
| Last Updated: | October 2, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Asenapine Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 16, 2013