Status:
COMPLETED
An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Psychosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 29 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2005
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00878462
Start Date
June 29 2005
End Date
October 15 2005
Last Update
August 15 2024
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