Clareo Health | An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Organon and Co
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
