Psychosis
Conditions
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.
Interventions
DRUGAsenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
DRUGAsenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
DRUGAsenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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? | 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
| Measure | 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) |
Outcome results
None listed