Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Organon and Co
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Minimum age of 20 years
Participants who meet at least one of the following:
* current diagnosis of schizophrenia of residual subtype
* received treatment with 3 or more antipsychotic drugs
* treatment-refractory participants with schizophrenia
* 65 years old and over with positive schizophrenia symptoms with score of 3 (mild) or more in 1 or more items in the positive subscale of the Positive and Negative Syndrome Scale (PANSS) at the baseline
Participants who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline
You may not be if
Uncontrolled, unstable clinically significant medical condition
Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening
Positive pregnancy test at Screening, or the intention to become pregnant during the course of the study
Seizure disorder beyond childhood (12 years old or younger)
History of neuroleptic malignant syndrome
Allergy or sensitivity to drugs such as psychotropics and antipsychotics
Known history of or currently treated for narrow angle glaucoma
Parkinson's disease
Diagnosis of schizoaffective disorder; schizophreniform disorder
Concurrent psychiatric disorder other than schizophrenia coded on Axis I; a primary diagnosis other than schizophrenia
Diagnosis of borderline personality disorder
Diagnosis of mental retardation or organic brain disorder
Current (past 6 months) substance abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (excluding nicotine)
Positive drug/alcohol tests at the Screening visit
Imminent risk of self-harm or harm to others, in the Investigator's opinion
Substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
Currently under involuntary inpatient confinement
Use of a non-approved drug in Japan within 12 weeks prior to informed consent
Previously treated in an asenapine study
Clareo Health | Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
