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

• Status: Completed
• Trial end date: 2014-08-21
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Asenapine

Criteria

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