Phase 3
Completed N=157
Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
Source: ClinicalTrials.gov NCT01244828 ↗Enrolled (actual)
157
Serious AEs
8.9%
Results posted
Aug 2015
Primary outcomePrimary: Change From Baseline in Weight at Week 52 — 0.25 kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weight at Week 52 |
0.25 | — |
| PRIMARY Change From Baseline in BMI at Week 52 |
0.07 | — |
| PRIMARY Number of Participants With Extrapyramidal Symptoms |
24; 3; 3; 2; 10; 1 | — |
| PRIMARY Change From Baseline in HbA1c at Week 52 |
0.00 | — |
| PRIMARY Change From Baseline in Fasting Glucose at Week 52 |
0.11 | — |
| PRIMARY Change From Baseline in Insulin at Week 52 |
2.31 | — |
| PRIMARY Change From Baseline in Prolactin at Week 52 |
0.66 | — |
| PRIMARY Change From Baseline in PANSS Total Score at Week 52 |
-11.08 | — |
| PRIMARY Change From Baseline in PANSS Total Score at Final Assessment |
-5.48 | — |
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
Data sourced from ClinicalTrials.gov (NCT01244828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.