Clinical trial NCT01244828: Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
Official title: Long-term Study of Asenapine in Subjects With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (Protocol P06238)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 157
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Weight at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in BMI at Week 52
timeFrame: Baseline and Week 52
measure: Number of Participants With Extrapyramidal Symptoms
timeFrame: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
measure: Change From Baseline in HbA1c at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Fasting Glucose at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Insulin at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Prolactin at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in PANSS Total Score at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in PANSS Total Score at Final Assessment
timeFrame: Baseline up to Week 52
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: