Clinical trial NCT00878462: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psychosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-04-09
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: 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?""
timeFrame: After each dose (morning and evening of days 1 through 3)
measure: 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?"
timeFrame: After each dose (morning and evening of days 1 through 3)
Secondary outcomes:
measure: Responses on the following question: "How acceptable was the taste of the tablet?"
timeFrame: After each dose (morning and evening of days 1 through 3)
Other outcomes:
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