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

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878462
• Other study ID #: P07010
• Secondary ID: A7501024
• Status: Completed
• Phase: Phase 2
• Start date: June 29, 2005
• Est. completion date: October 15, 2005

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: October 15, 2005
• Est. primary completion date: October 15, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Responses on the following question: "How acceptable was the taste of the tablet?"		After each dose (morning and evening of days 1 through 3)