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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00878462
First received: April 8, 2009
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Psychosis
Drug: Asenapine WHITE raspberry flavor (Treatment A)
Drug: Asenapine RED raspberry flavor (Treatment B)
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Randomized, Crossover Study Evaluating the Acceptability of Unflavored Asenapine and Raspberry Flavored Asenapine in Stable Subjects With A Psychotic Disorder

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: June 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274
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:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274
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:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274
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:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274
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:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274
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:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine RED raspberry flavor (Treatment B)
Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274
Drug: Asenapine WHITE UNFLAVORED (Treatment C)
Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
Other Names:
  • Saphris
  • Org 5222
  • SCH 900274

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00878462     History of Changes
Other Study ID Numbers: P07010, A7501024
Study First Received: April 8, 2009
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014