A Randomized, Crossover Study Evaluating the Acceptability of Unflavored Asenapine and Raspberry Flavored Asenapine in Stable Subjects With A Psychotic Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 174
- 主要终点
- 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?""
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Asenapine WHITE raspberry flavor (Treatment A) (Drug)
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.
干预措施: Asenapine RED raspberry flavor (Treatment B) (Drug)
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.
干预措施: Asenapine WHITE UNFLAVORED (Treatment C) (Drug)
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.
干预措施: Asenapine WHITE raspberry flavor (Treatment A) (Drug)
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.
干预措施: Asenapine RED raspberry flavor (Treatment B) (Drug)
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.
干预措施: Asenapine WHITE UNFLAVORED (Treatment C) (Drug)
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.
干预措施: Asenapine WHITE raspberry flavor (Treatment A) (Drug)
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.
干预措施: Asenapine RED raspberry flavor (Treatment B) (Drug)
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.
干预措施: Asenapine WHITE UNFLAVORED (Treatment C) (Drug)
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.
干预措施: Asenapine WHITE raspberry flavor (Treatment A) (Drug)
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.
干预措施: Asenapine RED raspberry flavor (Treatment B) (Drug)
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.
干预措施: Asenapine WHITE UNFLAVORED (Treatment C) (Drug)
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.
干预措施: Asenapine WHITE raspberry flavor (Treatment A) (Drug)
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.
干预措施: Asenapine RED raspberry flavor (Treatment B) (Drug)
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.
干预措施: Asenapine WHITE UNFLAVORED (Treatment C) (Drug)
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.
干预措施: Asenapine WHITE raspberry flavor (Treatment A) (Drug)
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.
干预措施: Asenapine RED raspberry flavor (Treatment B) (Drug)
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.
干预措施: Asenapine WHITE UNFLAVORED (Treatment C) (Drug)
结局指标
主要结局
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?""
时间窗: 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?"
时间窗: After each dose (morning and evening of days 1 through 3)
次要结局
- Responses on the following question: "How acceptable was the taste of the tablet?"(After each dose (morning and evening of days 1 through 3))