Clinical trial

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

Name

P06238

Description

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.

Trial arms

Trial start

2011-04-05

Estimated PCD

2014-08-21

Trial end

2014-08-21

Status

Completed

Phase

Early phase I

Treatment

Asenapine

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

Arms:

Asenapine

Size

157

Primary endpoint

Change From Baseline in Weight at Week 52

Baseline and Week 52

Change From Baseline in BMI at Week 52

Baseline and Week 52

Number of Participants With Extrapyramidal Symptoms

Up to 30 days after last dose of study drug (Up to approximately 56 weeks)

Change From Baseline in HbA1c at Week 52

Baseline and Week 52

Change From Baseline in Fasting Glucose at Week 52

Baseline and Week 52

Change From Baseline in Insulin at Week 52

Baseline and Week 52

Change From Baseline in Prolactin at Week 52

Baseline and Week 52

Change From Baseline in PANSS Total Score at Week 52

Baseline and Week 52

Change From Baseline in PANSS Total Score at Final Assessment

Baseline up to Week 52

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 157, 'type': 'ACTUAL'}}

Updated at

2024-05-28

1 organization

1 product

1 indication

Organization

Organon and Co

Product

Asenapine

Indication

Schizophrenia