Status:
COMPLETED
Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
Lead Sponsor:
Organon and Co
Conditions:
Schizophrenia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in participants with schizophrenia. Participants in this study consist of schizophrenia with residual subtype or recei...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 5 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2014
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT01244828
Start Date
April 5 2011
End Date
August 21 2014
Last Update
May 28 2024
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