NCT00878462

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-06-29
• Primary completion: 2005-10-15
• Completion: 2005-10-15
• First posted: 2009-04-09
• Last updated: 2024-08-15