Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)

Organon

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Asenapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01244828

132325 (Registry Identifier)

MK-8274-042 (Other Identifier)

P06238

Details and patient eligibility

About

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 receiving high dose/multiple antipsychotic drugs, treatment refractory, or elderly participants with schizophrenia. The treatment period is up to 52 weeks.

Enrollment

157 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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