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

August 13, 2024 updated by: Organon and Co

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
174

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Experimental: 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.
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Experimental: 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.
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Experimental: 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.
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Experimental: 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.
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Experimental: 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.
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Org 5222
  • SCH 900274
  • Saphris

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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?""
Time Frame: After each dose (morning and evening of days 1 through 3)
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?"
Time Frame: After each dose (morning and evening of days 1 through 3)
After each dose (morning and evening of days 1 through 3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Responses on the following question: "How acceptable was the taste of the tablet?"
Time Frame: After each dose (morning and evening of days 1 through 3)
After each dose (morning and evening of days 1 through 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P07010
  • A7501024

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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