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

Organon

Status and phase: Completed; Phase 2

Conditions: Psychosis

Treatments: Drug: Asenapine WHITE UNFLAVORED (Treatment C); Drug: Asenapine RED raspberry flavor (Treatment B); Drug: Asenapine WHITE raspberry flavor (Treatment A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00878462

A7501024

P07010

Details and patient eligibility

About

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 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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

174 participants in 6 patient groups

Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: Asenapine WHITE raspberry flavor (Treatment A)

Drug: Asenapine RED raspberry flavor (Treatment B)

Drug: Asenapine WHITE UNFLAVORED (Treatment C)

Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: Asenapine WHITE raspberry flavor (Treatment A)

Drug: Asenapine RED raspberry flavor (Treatment B)

Drug: Asenapine WHITE UNFLAVORED (Treatment C)

Sequence 3

Experimental group

Description:

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.

Treatment:

Drug: Asenapine WHITE raspberry flavor (Treatment A)

Drug: Asenapine RED raspberry flavor (Treatment B)

Drug: Asenapine WHITE UNFLAVORED (Treatment C)

Sequence 4

Experimental group

Description:

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.

Treatment:

Drug: Asenapine WHITE raspberry flavor (Treatment A)

Drug: Asenapine RED raspberry flavor (Treatment B)

Drug: Asenapine WHITE UNFLAVORED (Treatment C)

Sequence 5

Experimental group

Description:

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.

Treatment:

Drug: Asenapine WHITE raspberry flavor (Treatment A)

Drug: Asenapine RED raspberry flavor (Treatment B)

Drug: Asenapine WHITE UNFLAVORED (Treatment C)

Sequence 6

Experimental group

Description:

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.

Treatment:

Drug: Asenapine WHITE raspberry flavor (Treatment A)

Drug: Asenapine RED raspberry flavor (Treatment B)

Drug: Asenapine WHITE UNFLAVORED (Treatment C)