NCT00878462

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2005

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

April 8, 2009

Last Update Submit

August 13, 2024

Conditions

Psychosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Responses on the following question: "How acceptable was the taste of the tablet?"

    After each dose (morning and evening of days 1 through 3)

Study Arms (6)

Sequence 1

EXPERIMENTAL

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.

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

Sequence 2

EXPERIMENTAL

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.

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

Sequence 3

EXPERIMENTAL

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.

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

Sequence 4

EXPERIMENTAL

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.

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

Sequence 5

EXPERIMENTAL

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.

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

Sequence 6

EXPERIMENTAL

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.

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

Interventions

Asenapine WHITE raspberry flavor (Treatment A)DRUG

Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets

Also known as: Saphris, Org 5222, SCH 900274
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Asenapine RED raspberry flavor (Treatment B)DRUG

Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets

Also known as: Saphris, Org 5222, SCH 900274
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Asenapine WHITE UNFLAVORED (Treatment C)DRUG

Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets

Also known as: Saphris, Org 5222, SCH 900274
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic Disorders

Interventions

asenapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2009

First Posted

April 9, 2009

Study Start

June 29, 2005

Primary Completion

October 15, 2005

Study Completion

October 15, 2005

Last Updated

August 15, 2024

Record last verified: 2022-02