An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)
Phase 2
Completed
- Conditions
- Psychosis
- Interventions
- Registration Number
- NCT00878462
- Lead Sponsor
- Organon and Co
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 Asenapine RED raspberry flavor (Treatment B) 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. Sequence 2 Asenapine RED raspberry flavor (Treatment B) 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. Sequence 3 Asenapine WHITE raspberry flavor (Treatment A) 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. Sequence 3 Asenapine WHITE UNFLAVORED (Treatment C) 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. Sequence 4 Asenapine WHITE raspberry flavor (Treatment A) 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. Sequence 5 Asenapine WHITE raspberry flavor (Treatment A) 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. Sequence 5 Asenapine WHITE UNFLAVORED (Treatment C) 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. Sequence 6 Asenapine WHITE raspberry flavor (Treatment A) 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. Sequence 6 Asenapine RED raspberry flavor (Treatment B) 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. Sequence 1 Asenapine WHITE raspberry flavor (Treatment A) 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. Sequence 2 Asenapine WHITE UNFLAVORED (Treatment C) 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. Sequence 1 Asenapine WHITE UNFLAVORED (Treatment C) 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. Sequence 2 Asenapine WHITE raspberry flavor (Treatment A) 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. Sequence 3 Asenapine RED raspberry flavor (Treatment B) 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. Sequence 4 Asenapine WHITE UNFLAVORED (Treatment C) 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. Sequence 4 Asenapine RED raspberry flavor (Treatment B) 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. Sequence 5 Asenapine RED raspberry flavor (Treatment B) 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. Sequence 6 Asenapine WHITE UNFLAVORED (Treatment C) 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Responses on the following question: "How acceptable was the taste of the tablet?" After each dose (morning and evening of days 1 through 3)