An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)

Overview

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.

Full Title of Study: “A Randomized, Crossover Study Evaluating the Acceptability of Unflavored Asenapine and Raspberry Flavored Asenapine in Stable Subjects With A Psychotic Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 15, 2005

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

  • Drug: Asenapine WHITE raspberry flavor (Treatment A)
    • Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
  • Drug: Asenapine RED raspberry flavor (Treatment B)
    • Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
  • Drug: Asenapine WHITE UNFLAVORED (Treatment C)
    • Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary 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)
  • 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 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Organon and Co
  • Provider of Information About this Clinical Study
    • Sponsor

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