Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and Hig… (NCT01244828) | Clinical Trial Compass
CompletedPhase 3
Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
157 participantsStarted 2011-04-05
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Cur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Weight at Week 52
Timeframe: Baseline and Week 52
2
Change From Baseline in BMI at Week 52
Timeframe: Baseline and Week 52
3
Number of Participants With Extrapyramidal Symptoms
Timeframe: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
4
Change From Baseline in HbA1c at Week 52
Timeframe: Baseline and Week 52
5
Change From Baseline in Fasting Glucose at Week 52