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

NCT ID: NCT01244828

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-05
• Study Completion Date: 2014-08-21

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

Conditions

Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Asenapine

Asenapine 5 mg twice daily (BID) for the first week of treatment, then either 5 mg or 10 mg BID.

Group Type: EXPERIMENTAL

Asenapine

Intervention Type: DRUG

5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks

Interventions

Asenapine

5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

132325

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-8274-042

Identifier Type: OTHER

Identifier Source: secondary_id

P06238

Identifier Type: -

Identifier Source: org_study_id