PsychosisPhase 2NCT00878462

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

A Phase 2 study testing Asenapine WHITE raspberry flavor (Treatment A), Asenapine RED raspberry flavor (Treatment B) and Asenapine WHITE UNFLAVORED (Treatment C) in people with Psychosis, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Psychosis
What is being tested?: Asenapine WHITE raspberry flavor (Treatment A), Asenapine RED raspberry flavor (Treatment B) and Asenapine WHITE UNFLAVORED (Treatment C)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 174 participants
Where: No sites listed yet
Study dates: 29 Jun 2005to 15 Oct 2005
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 12Show fewer

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.

About this study

Official title: 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.

Read the 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
Being tested: Asenapine WHITE raspberry flavor (Treatment A), Asenapine RED raspberry flavor (Treatment B), Asenapine WHITE UNFLAVORED (Treatment C)
Medical subject headings: Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Asenapine WHITE raspberry flavor (Treatment A)Drug
Also called Saphris, Org 5222, SCH 900274
Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
Asenapine RED raspberry flavor (Treatment B)Drug
Also called Saphris, Org 5222, SCH 900274
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Asenapine WHITE UNFLAVORED (Treatment C)Drug
Also called Saphris, Org 5222, SCH 900274
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets

Study groups in NCT00878462
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Asenapine WHITE raspberry flavor (Treatment A); Drug: Asenapine RED raspberry flavor (Treatment B); Drug: Asenapine WHITE UNFLAVORED (Treatment C)

What is being measured

The primary outcome is the main question the study is designed to answer.

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?""
Measured: 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?"
Measured: 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?"
Measured: After each dose (morning and evening of days 1 through 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 200515 Oct 2005

First posted9 Apr 2009 (estimated)
Study start29 Jun 2005
Primary completion15 Oct 2005
Study completion15 Oct 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PsychosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00878462
Sponsor's protocol ID: P07010
Other IDs: A7501024
Status last verified: Feb 2022
First submitted: 8 Apr 2009
Last updated: 15 Aug 2024
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Crossover Study Evaluating the Acceptability of Unflavored Asenapine and Raspberry Flavored Asenapine in Stable Subjects With A Psychotic Disorder
ClinicalTrials.gov ID: NCT00878462
Acronym / sponsor ID: P07010
Conditions: Psychosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 174 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 29 Jun 2005 (actual)
Primary completion: 15 Oct 2005 (actual)
Study completion: 15 Oct 2005 (actual)
First posted: 9 Apr 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1	Experimental	Drug: Asenapine WHITE raspberry flavor (Treatment A), Drug: Asenapine RED raspberry flavor (Treatment B), Drug: Asenapine WHITE UNFLAVORED (Treatment C)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.
Sequence 2	Experimental	Drug: Asenapine WHITE raspberry flavor (Treatment A), Drug: Asenapine RED raspberry flavor (Treatment B), Drug: Asenapine WHITE UNFLAVORED (Treatment C)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.
Sequence 3	Experimental	Drug: Asenapine WHITE raspberry flavor (Treatment A), Drug: Asenapine RED raspberry flavor (Treatment B), Drug: Asenapine WHITE UNFLAVORED (Treatment C)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.
Sequence 4	Experimental	Drug: Asenapine WHITE raspberry flavor (Treatment A), Drug: Asenapine RED raspberry flavor (Treatment B), Drug: Asenapine WHITE UNFLAVORED (Treatment C)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.
Sequence 5	Experimental	Drug: Asenapine WHITE raspberry flavor (Treatment A), Drug: Asenapine RED raspberry flavor (Treatment B), Drug: Asenapine WHITE UNFLAVORED (Treatment C)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.
Sequence 6	Experimental	Drug: Asenapine WHITE raspberry flavor (Treatment A), Drug: Asenapine RED raspberry flavor (Treatment B), Drug: Asenapine WHITE UNFLAVORED (Treatment C)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Asenapine WHITE raspberry flavor (Treatment A)Also: Saphris, Org 5222, SCH 900274Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
Asenapine RED raspberry flavor (Treatment B)Also: Saphris, Org 5222, SCH 900274Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
Asenapine WHITE UNFLAVORED (Treatment C)Also: Saphris, Org 5222, SCH 900274Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

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)
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)

1 secondary outcome

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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.

Related trials for Psychosis

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Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
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Not yet recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00878462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.